Abbott Diabetes Care is recalling as many as 359 million glucose test strips sold earlier this year because they may reveal falsely low glucose results, posing a health risk. The brands of test strips are sold at retail and are used at hospitals and health care facilities in the U.S. and Puerto Rico. The company said it discovered the problem during an internal quality review.
According to a statement by the Food and Drug Administration, it is possible that test strips in the 359 lots involved in the recall require longer than normal blood fill times and may not be absorbing enough blood for proper monitoring. “Strips exposed to warm weather or prolonged storage may be more likely to provide a false result,” the FDA said. Warm weather is considered between 72°F and 86°F.
If glucose test strips falsely report blood glucose levels, there is a risk that hyperglycemia (high blood sugar) will go unrecognized, or the result will falsely report that a patient is hypoglycemic (low blood sugar). Patients may unwittingly try to offset the results by either raising blood glucose levels or not treating elevated blood glucose.
The recall affects certain lots of the following brand names, sold between January and September 2010:
- Precision Xceed Pro
- Precision Xtra
- Medisense Optium
- Optium
- Optium EZ
- ReliOn Ultima
To determine if you have an affected lot, visit www.precisionoptiuminfo.com, which is a special web site set up by Abbott, or call 1-800-448-5234. Lot codes are listed on the bottom of the box. For consumers who purchased Precision Xtra, Optium, Optium EZ, and ReliOn Ultima brand test strips at a retailer or online, Abbott will replace affected strips at no charge. For consumers who have a partial package in their possession, the company said it will provide a complete package as a replacement.
Health care professionals using Precision Xceed Pro are being advised to switch to test strips from unaffected lots.
While Abbott recommends discontinuing use of the affected products, customers who cannot locate unaffected lots while they are waiting for a replacement should still use the affected test strips, and follow these instructions by Abbott.
Abbott Diabetes Care is a division of Abbott Laboratories, Abbott Park, IL.
More details:
FDA Questions & Answers about Abbott Glucose Test Strip Recall
