FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Gluc
FDA device recall Z-0485-2014 · posted 2013-12-17 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
- Action taken
- Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps: Call Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. While waiting for replacement strips to arrive, use an alternate method to measure their blood glucose. If only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. Customers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. Customers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869. For questions regarding this recall call 510-239-2775. Abbott issued a press release at the request of CDRH on november 27, 2013.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 141,219 cartons for human use - all lot numbers
- Distribution
- Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxemb
- Date initiated
- 2013-11-18
- Date posted
- 2013-12-17
- Date terminated
- 2015-08-03
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (K092602) | Abbott Diabetes Care, Inc. | 2010-05-14 |