Device recall
Z-1598-2022: Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson…
FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office
Key facts
| Recall number (Z-number) | Z-1598-2022 |
|---|---|
| Recall event | 90336 |
| Product | Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson… |
| Product code | GTY |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K010582 |
| 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