Device recall
Z-2282-2016: Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one…
FDA device recall · Class III · Tosoh Bioscience, Inc.
Key facts
| Recall number (Z-number) | Z-2282-2016 |
|---|---|
| Recall event | 74452 |
| Product | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction. |
| Product code | JIT |
| Recalling firm | Tosoh Bioscience, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 22, 2017 |
| 510(k) numbers | K153417 |
| FEI number | 1000123732 |
At a glance
- 1–9 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