IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Reported: November 20, 2024 Initiated: September 30, 2024 #Z-0464-2025
Product Description
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
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).
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 7,332 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 7,332 units.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2024. Severity: Moderate. Recall number: Z-0464-2025.
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