NEWS | Jan. 4, 2011

Abbott glucose test strips recall at Naval Health Clinic Charleston

By Naval Health Clinic Charleston Public Affairs

Based on recommendations from the U.S. Food and Drug Administration issued on Dec. 22, 2010, Naval Health Clinic Charleston is recalling different lots of Abbot Diabetes Care glucose test strips.

According to the FDA, 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 test strips are marketed under the following brand names, specifically the Precision Xtra Blood Glucose Test Strips; Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. The test 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 FDA, working with Abbot Diabetes Care, notes that 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.

If the test stripes have been stored in 86 degrees F or higher they are most likely defective because the heat affects a portion of the strip that determines the actual glucose reading.

If it takes longer than five seconds to get a reading once the blood hits the strip while in the meter, the strip is defective, most likely due to excessive heat. If it takes less than five seconds, there should not be an issue and use of the strips is acceptable.

Patients who have received test strips are encouraged to check the list of lot numbers below, or call NHCC Pharmacy at 794-6100 for clarification. If any patient has stored any test strips on the list in 86 degrees Fahrenheit heat or higher, please return to the pharmacy for replacement. If it takes longer than five seconds to get a reading, and the test strips are on the list, return to the pharmacy.

Additionally, patients can 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.

Precision Xtra Blood Glucose Test Strips that have been affected by the Abbott recall of December 22, 2010 which may have been affected by excessive heat that could cause a false low blood glucose reading:

45001A330, 45001A467, 45001A481, 45001A482, 45001A483, 45001A487, 45001A488, 45001A496, 45001A497, 45001A499, 45001A500, 45001A503, 45001A505, 45001A506, 45001A510, 45001A511, 45001A513, 45001A519, 45001A520, 45001A521, 45001A530, 45001A532, 45001A534, 45001A536, 45001A537, 45001A545, 45001A556, 45001A565, 45001A566, 45001A568, 45001A573, 45001A577, 45001A584, 45001A594, 45001A595, 45001A597, 45001A605, 45001A607, 45001A608, 45001A609, 45001A613, 45001A614,
45001A626, 45001A634, 45001A637, 45001A641, 45001A644, 45001A645, 45001A656, 45001A660, 45001A664, 45001A669, 45001A670, 45001A671, 45001A677, 45001A678, 45001A682, 45001A685, 45001A694, 45001A700, 45001A705, 45001A706, 45001A707, 45001A709, 45001A712, 45001A730, 45001A732, 45001A739, 45001A742, 45001A744, 45001A751, 45001A753, 45001A757, 45001A762, 45001A777, 45001A778, 45001A786, 45001A788, 45001A790, 45001A798, 45001A806, 45001A814, 45001A815, 45001A816,
45001A820, 45001A840, 45001A842, 45001A847, 45001A852, 45001A856, 45001A860, 45001A861, 45001A872, 45001A876, 45001A882, 45001A910, 45001A912, 45001A914, 45001A918, 45001A920, 45001A921, 45001A940, 45001A947, 45001A948, 45001A949, 45001A971, 45001A976, 45001A979, 45001A982, 45001A983, 45001C008, 45001C011, 45001C012 45384, 45388, 45396, 45407, 45418, 45455, 45456, 45463, 45464, 45512, 45514, 45516, 45521, 45611, 45612, 45614, 45619, 45627, 45632, 45639, 45645, 45646, 45653, 45670, 45679, 45680, 45682, 45707, 45708, 45724, 45729, 45731, 45732, 45733, 45735, 45737, 45738, 45755, 45777, 45782, 45783, 45784