Reported Nov 20, 2024 · Ongoing
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00630414982212UDI - 00630414982212, Lot Number D164 2 00630414982229SMN 10706282: UDI - 00630414982229, Lot Number D166 3 00630414961958SMN 10380896 (OUS): UDI - 00630414961958 4 00630414961965SMN 10380996 (OUS): UDI - 00630414961965 5 OUS Lot Numbers: 438, 439, 440 - Amount recalled
- 7,332 units
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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