Device recall
Z-0118-2025: IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0118-2025 |
|---|---|
| Recall event | 95285 |
| Product | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry. |
| Product code | DEW |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K963868 |
| FEI number | 2050012 |
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