Up to 359 Million Abbott Glucose Test Strips Recalled
When exposed to warm weather or prolonged storage, they may be more likely to show a false result, the company and FDA announced Wednesday.
Abbott Diabetes Care and the U.S. Food and Drug Administration on Wednesday announced the company has recalled as many as 359 million Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima glucose test strips because of a defect that may cause them to produce false results. The defect inhibits sufficient absorption of blood into the strip. Strips that are exposed to warm weather or prolonged storage may be more likely to provide a false result, according to the recall notice.
Abbott Diabetes Care has posted an online page showing how to locate the lot number on its products to check whether they have been recalled. The test strips were manufactured between January and May 2010 and have been sold in retail outlets and online directly to consumers. They are also used in health care facilities. The company is recalling 359 different lots of the strips.
FDA asked health care professionals and patients to report any adverse event or side effect related to the use of the products to its MedWatch Safety Information and Adverse Event Reporting Program in these ways:
- Complete and submit an online report at www.fda.gov/MedWatch/report.htm.
- Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form or fax to 1-800-FDA-0178.