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Questions and Answers About the Abbott Glucose Test Strip Recall

Wed, 12/22/2010 - 9:31am
U.S. Food & Drug Administration

What products are affected?

Abbott Diabetes Care is recalling 359 different lots of glucose test strips. The strips include the following brands:

  • Medisense Optium
  • Optium
  • OptiumEZ
  • Prescision Xtra
  • ReliOn Ultima
  • Precision Xceed Pro

These strips are used with the following blood glucose monitoring systems:

  • MediSense Optium
  • Optium
  • OptiumEZ
  • Precision Xtra
  • ReliOn Ultima
  • Precision Xceed Pro

The blood glucose monitoring systems are not being recalled.  Customers should continue using their blood glucose monitors.

The recall pertains to certain lots of glucose test strips that were distributed in the United States and Puerto Rico. No other Abbott Diabetes Care products are affected.  As many as 359 million test strips may be affected.

The strips were manufactured between January and May 2010.  They were sold both in retail settings to consumers and are also used in health care facilities

How can I tell which lots of glucose test strips are being recalled?

Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com.

Or customers can also call the following numbers for more information:

  • Customers with Precision Xtra, Medisense Optium, Optium, OpiumEZ, ReliOn and Precision Xceed Pro test strips can call Abbott Diabetes Customer Care Service at 1-800-448-5234 for English and 1-800-709-7010 for Spanish.
  • Precision Xceed Pro test strip customers can call 1-877-529-7185.

The lot numbers appear on the bottom of the test strip box and on each individually foil-wrapped test strip packet. Abbott Diabetes Care’s website www.precisionoptiuminfo.com provides of box this information.

Why is Abbott recalling the test strips?

The lot numbers under recall may give falsely low blood glucose results.

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.

What risk is associated with using the recalled test strips?

Because the test strips are incorrectly reporting low blood glucose, there is a risk that hyperglycemia (high blood sugar) will go unrecognized, or that a meter will falsely report a patient is hypoglycemic (low blood sugar).  This can lead users to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.  Both scenarios pose health risks.

Information for patients using test strips at home:

  • What should I do if I have affected test strips?

If you have test strips from the affected lots, switch to using another lot that is not affected by this recall immediately. If you do not have test strips from another lot you should try to obtain them as soon as possible.  Abbott Diabetes Care will replace the recalled strips no charge. Call Abbott Diabetes Customer Care Service at 1-800-448-5234 for English and 1-800-709-7010 for Spanish.

  • What should I do if I cannot immediately replace my test strips?

If another lot is not immediately available, but you do have access to another blood glucose testing system, you should use the other system until you can obtain unaffected replacement test strips.

If another lot is not immediately available and you do not have access to another blood glucose testing system, continue to check your blood glucose. But, take the following precautions when using affected strips:

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.  You should 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.  

If any reading appears lower than you would expect or does not seem to correlate with the way you are feeling you should contact your health care provider immediately.

Precaution 2:

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 sugar 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.

Information for Hospitals, Nursing Homes, Assisted Living Centers, and Other Health Care Facilities:

  • What should health care facilities with these test strips do?

Stop using the recalled test strips and instead use test strips from unaffected lots.

  • What should health care facilities that do not have access to unaffected lots do?

If the facility does not have any test strips from unaffected lots and the facility has an alternative point-of-care blood glucose testing system, the company is recommending the facility begin using the alternative system until you can obtain new test strips not subject to recall.

If the facility does not have any test strips from unaffected lots and does not have immediate access to an alternative point-of-care blood glucose testing system, health care providers should take the following additional steps:

  • 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. Clinical judgement should be applied when deciding whether to act on results prior to verification;
  • 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;
  • Monitor the amount of time it takes for the Precision Xceed Pro Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five seconds, discard that test strip immediately because the blood glucose result will be erroneously low. (If this occurs, health care providers should note the lot number of that test strip, discard all the test strips from that lot, and notify Abbott Diabetes Care immediately by calling 1-877-529-7185).

Will there be a shortage of Abbott glucose test strips?

Because these test strips are sold in retail stores to individual patients for home use and are also used in hospitals and user facilities, the FDA is working with Abbott to avoid any potential product shortages.

As part of this effort, FDA is asking health care facilities to use alternative point-of-care testing systems, as described above, until Abbott can replace the affected test strips.  Abbott has a limited supply of the Precision Xceed Pro test strips, which are used in health care facilities, in inventory and cannot replace all of these strips immediately.  They will start replacing some test strips immediately; but, according to information supplied by Abbott, it will take approximately 8 weeks to produce and distribute enough strips to replace all of the defective strips that have been distributed to health care facilities.

Abbott has enough home-use test strips in inventory to replace all affected test strips.  Home-use customers should replace their test strips immediately.

Where can I get additional information on this recall?

Abbott Diabetes Care

  • Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com
  • By calling Abbott Diabetes Customer Care Service at 1-800-448-5234 for English and 1-800-709-7010 for Spanish

FDA

How can I report problems to the FDA?

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

 

    

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