Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be
FDA device recall Z-0171-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Provalis Diagnostics
- Reason for recall
- Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.
- Action taken
- All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 838 Kits of 10 test devices each
- Distribution
- Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
- Date initiated
- 2005-05-20
- Date posted
- 2005-11-18
- Date terminated
- 2012-05-03
- Location
- Orlando, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G5 I HBA1C TEST, G5 II HBA1C TEST (K041635) | Provalis Diagnostics , Ltd. | 2004-08-16 |