Recall Z-1821-2025— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498. Reason: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-15
- Firm location
- East Walpole, MA, United States
Product description
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reason for recall
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Data sourced from openFDA. This site is unofficial and independent of the FDA.