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Recall Observatory FDA recall evidence

Device product

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

Z-0464-2025

September 30, 2024

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 95513
Status
Ongoing
Classification
Class II
Quantity
7,332 units
Official record key
device-enforcement:Z-0464-2025

Official wording

Reason: 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).

Code information: 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 pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).