Recall Z-1546-05 ยท LFR Glucose Dehydrogenase, Glucose
CHdiagnostics
SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
| Date | Sep 15, 2005 (initiated Mar 14, 2005) |
| Status | Terminated |
| Reason | A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level. |
| Root cause | Other |
| Action | Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots. |
| Quantity | 43,138 vials |
| Distribution | AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032076 | SENOVA(R) BLOOD GLUCOSE MONITOR Chdiagnostics, LLC, Sep 30, 2003 |