Device recall
Z-0171-06: Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is…
FDA device recall · Class II · Provalis Diagnostics
Key facts
| Recall number (Z-number) | Z-0171-06 |
|---|---|
| Recall event | 32571 |
| Product | Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of… |
| Product code | LCP |
| Recalling firm | Provalis Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2012 |
| 510(k) numbers | K041635 |
| FEI number | 3004950843 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database