Siemens Healthcare Diagnostics, Inc.: Device Recall
Recall #Z-0464-2025 · 09/30/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0464-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Status
- Ongoing
- Date Initiated
- 09/30/2024
- Location
- East Walpole, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,332 units
Reason for Recall
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Product Description
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Distribution Pattern
Worldwide - US Nationwide distribution.
Other Recalls by Siemens Healthcare Diagnostics, Inc.
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 09/22/2025
- Class II: Risk 08/11/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.