Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System;
FDA device recall Z-0999-2011 · posted 2011-02-09 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 359 total lots, 1,000,000 strips per lot.
- Distribution
- Products were released for distribution in US and Puerto Rico.
- Date initiated
- 2010-12-22
- Date posted
- 2011-02-09
- Date terminated
- 2011-10-25
- Location
- Alameda, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |