Drug recall
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of…
FDA recall event 95666 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 95666 |
|---|---|
| Recall numbers | Z-0599-2025 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent. |
| Initiation date | Oct 21, 2024 |
| Report date | Dec 11, 2024 |
| City | Tarrytown |
| State | NY |
| Country | United States |
| FEI number | 2432235 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: