Device recall
Z-1606-2022: a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG…
FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office
Key facts
| Recall number (Z-number) | Z-1606-2022 |
|---|---|
| Recall event | 90336 |
| Product | a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211. |
| Product code | JHI |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K062361 |
| FEI number | 3004386693 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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