Device recall
Z-0997-2026: BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is…
FDA device recall · Class II · Beckman Coulter Ireland, Inc.
Key facts
| Recall number (Z-number) | Z-0997-2026 |
|---|---|
| Recall event | 97842 |
| Product | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. |
| Product code | KHS |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131546 |
| FEI number | 1000206808 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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