Recall Z-0599-2025— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2024-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-21
- Firm location
- Tarrytown, NY, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.