Device recall
Z-1840-2015: The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154…
FDA device recall · Class III · Bio-Rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1840-2015 |
|---|---|
| Recall event | 71406 |
| Product | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error. |
| Product code | JJX |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2015 |
| FEI number | 3008272466 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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