Device recall
Z-1583-2022: a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin…
FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office
Key facts
| Recall number (Z-number) | Z-1583-2022 |
|---|---|
| Recall event | 90336 |
| Product | a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10. |
| Product code | GJS |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093243, K183255 |
| 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