FDA Medical devices recall ·
IMMULITE 2000 PSA assay recall
- Recall number
- Z-0464-2025
- Date
- (initiated September 30, 2024)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
333 Coney St, East Walpole, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,332 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Why was it recalled?
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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
SMN 10706281: UDI - 00630414982212, Lot Number D164; SMN 10706282: UDI - 00630414982229, Lot Number D166; SMN 10380896 (OUS): UDI - 00630414961958; SMN 10380996 (OUS): UDI - 00630414961965; OUS Lot Numbers: 438, 439, 440
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0464-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.