Device recall
Z-1586-2022: a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General…
FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office
Key facts
| Recall number (Z-number) | Z-1586-2022 |
|---|---|
| Recall event | 90336 |
| Product | a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933 |
| Product code | CGX |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110530 |
| 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