Device recall
Z-1616-2014: ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1616-2014 |
|---|---|
| Recall event | 67961 |
| Product | ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact… |
| Product code | NBW |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2014 |
| 510(k) numbers | K113614 |
| FEI number | 1823260 |
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