FDA announces recall of Abbott glucose test strips

The U.S. Food and Drug Administration today (December 22) announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names:

* Precision Xceed Pro;
* Precision Xtra;
* Medisense Optium;
* Optium;
* OptiumEZ; and
* ReliOn Ultima

These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall.

The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall.

The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient’s health.

The recall is related to the test strips’ inability to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result.

The test strips were manufactured between January and September 2010 and are sold both in retail and online settings directly to consumers, but are also used in health care facilities.

The FDA has provided recommendations for consumers and health care professionals below that explain how to determine whether a particular lot is affected, how to order free replacement strips and how to use recalled strips to reduce the likelihood a false result.

“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”

To determine if you have product being recalled:

* Call Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish) to speak with a customer service representative.
* Visit www.precisionoptiuminfo.com to look up test strip lot numbers.

Consumers should report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

* Online
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
* Fax: 800-FDA-0178
* Phone: 800-332-1088

Recommendations for Consumers Who Purchased the Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Blood Glucose Test Strips

For consumers who purchased test strips in retail stories or online, FDA recommends:

* Calling Abbott for a replacement of the affected strips. Abbott will send you unaffected Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips at no charge.
* While waiting for the replacement strips to arrive, use an alternate method to measure blood glucose (such as a different test system) or purchase at least two weeks worth of new, unaffected strips while waiting for replacement strips.
* If you purchase Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips in a store or online, check to be sure these are from unaffected lots. Ask a pharmacist to help you.
* If the only test strips available to you are from affected lots, do not stop testing your blood glucose. But do take the following two precautions to reduce the chance of erroneous reading:

Precaution 1: Check the amount of time it takes for your blood glucose meter to start the “countdown” after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If your meter takes longer than five (5) seconds to start the countdown that test strip is defective and the result should not be used.

Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.

Precaution 2: If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.

Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).

* Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
* Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.

Recommendations for Health care Professionals using Precision Xceed Pro Blood Glucose System

If you have affected strips, FDA recommends the following:

* If available, immediately switch to using test strips from unaffected lots.
* If your facility does not have any test strips from unaffected lots, and you have immediate access to an alternate Point of Care blood glucose testing system within your healthcare facility, discontinue use of the Precision Xceed Pro Blood Glucose Test System and use the alternate method until you can obtain unaffected Precision Xceed Pro Blood Glucose Test Strip lots.
* If your facility does not have test strips from unaffected lots, and you do NOT have immediate access to an alternate Point of Care blood glucose testing system, FDA recommends the following procedures:

1. Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
2. Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
3. When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
i. Note the specific lot number of that test strip;
ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

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Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its Quality Standards

Abbott is initiating a proactive, voluntary recall of certain Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean.

Abbott is recalling these products following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product produced in one production area in a single manufacturing facility. The United States Food and Drug Administration (FDA) has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.

The recall of these powder infant formulas includes:

* Certain Similac powder product lines offered in plastic containers.
* Certain Similac powder product lines offered in sizes such as 8-ounce, 12.4-ounce and 12.9-ounce cans.

To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit www.similac.com/recall9, and type in their lot number to determine if their product is affected, or call (800) 986-8850.

No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas and all powder and liquid specialty formulas, such as Similac Expert Care™ Alimentum®, Elecare®, Similac Expert Care™ Neosure®, Similac® Human Milk Fortifier, and metabolic formulas for inherited disorders.

About the Recall

* The company is implementing a plan to address this matter in the affected manufacturing facility, which is expected to be completed shortly. No other facilities or products are involved in this recall.
* Abbott has consulted with the U.S. FDA regarding this recall.

Information for Parents and Caregivers

* Products with affected lot numbers should be returned to Abbott at no cost to the consumer.
* Parents and caregivers can go to www.similac.com/recall10 or call Abbott's consumer hotline, (800) 986-8850, 24 hours a day, seven days a week.
* Both the website and the consumer hotline have specific details on how to complete the return process.

Holger Liepmann, executive vice president, Abbott Nutrition said:

"Abbott understands that parents expect to feed their children only the highest quality product. We are taking this action so that parents know that the infant formula products they provide unquestionably meet the highest quality standards for which they are known. We regret any inconvenience this situation poses to parents and consumers."

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Abbott Nutrition Announces Voluntary Recall of Several ZonePerfect(R) Ba

Abbott Nutrition Announces Voluntary Recall of ZonePerfect(R) Chocolate Peanut Butter Bars, ZonePerfect(R) Peanut Toffee Bars and NutriPals(TM) Peanut Butter Chocolate Bars in U.S., Mexico, New Zealand and Singapore

/PRNewswire-FirstCall/ -- Abbott Nutrition today announced that it is initiating a precautionary, voluntary recall of ZonePerfect(R) Chocolate Peanut Butter bars, ZonePerfect(R) Peanut Toffee bars and NutriPals(TM) Peanut Butter Chocolate bars in response to the widening recall involving peanut butter and peanut paste ingredients manufactured by Peanut Corporation of America (PCA). PCA was one of the peanut ingredient suppliers to the company.

The specified Abbott Nutrition items, sold in the U.S. and internationally (Mexico, New Zealand and Singapore) in various packages and quantities, have not been linked to a nationwide salmonella outbreak and there have been no reported cases of the salmonella illness associated with ZonePerfect or NutriPals products. Abbott Nutrition tests every lot of finished ZonePerfect and NutriPals bars for salmonella and no salmonella contamination has been detected. This voluntary recall does not apply to Abbott Nutrition products sold in Canada.

Abbott Nutrition's action to issue a voluntary recall was supported by the U.S. Food & Drug Administration's advisement to manufacturers of an ongoing outbreak of salmonella involving peanut butter and peanut paste supplied by PCA. No other Abbott Nutrition products have been impacted by the PCA recall.

As part of its priority to ensure the safety and quality of all of its products, Abbott is issuing the voluntary recall. Abbott is working with retail partners to remove the specified products from retail store shelves and encouraging customers and consumers to verify if they have the specified products.

Consumers who have purchased the recalled products are urged to destroy the product. U.S. consumers with questions or who would like a refund may contact Abbott Nutrition Consumer Relations at (800) 986-8884, Monday through Friday, between the hours of 8:30 a.m. and 5:00 p.m. Eastern Time. Consumers with questions or concerns about their health should contact their doctor.

Products impacted by the voluntary withdrawal are as follows:

* ZonePerfect Chocolate Peanut Butter bars, all sizes and quantities
* ZonePerfect Peanut Toffee bars, all sizes and quantities
* NutriPals Peanut Butter Chocolate nutrition bars, all sizes and
quantities


For images of these products, please visit the following link:

http://abbottnutrition.com/pdf/peanut.pdf

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. For more information on Salmonella, please visit the Centers for Disease Control and Prevention's Website at http://www.cdc.gov/.

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