Abbott Diabetes Care, Optium Blood Glucose Test Strips;
FDA Recall Z-0997-2011 · Posted 2011-02-09
Advertisement
Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2010-12-22
Date Terminated2011-10-25
Product Quantity359 total lots, 1,000,000 strips per lot.
Reason for Recall
Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.
Firm Action
On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.
Root Cause
Process control
Distribution Pattern
Products were released for distribution in US and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement