Recall Z-0485-2014 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, uppe
| Date | Dec 17, 2013 (initiated Nov 18, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 b |
| Quantity | 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, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System Abbott Diabetes Care, Inc., May 14, 2010 |