SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter onl
FDA device recall Z-1546-05 · posted 2005-09-15 · Terminated
Recall details
- Recalling firm
- CHdiagnostics
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 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.
- Date initiated
- 2005-03-14
- Date posted
- 2005-09-15
- Date terminated
- 2007-01-23
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENOVA(R) BLOOD GLUCOSE MONITOR (K032076) | Chdiagnostics, LLC | 2003-09-30 |