Reported Feb 10, 2016 · Terminated
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293…
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?
- ADVIA Centaur PSA Assay
- Catalog Number06574155/SMN 10310292 (100
- test kit) and Catalog Number02676506/SMN 10310293 (500
- test kit) Product UsageThis in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems
- Lot codes and dates
- SMN 10310292-100 test kits Lot# UDI #SMN 10310293-500 test kits Lot# UDI #
546372630063041420300354637263160223553042630063041420300355304263160223562492640063041420300356249264160327767272640063041420300376727264160327008252650063041420300300825265160424924162650063041420300392416265160424991512650063041420300399151265160424129702660063041420300312970266160721141582660063041420300314158266160721230162660063041420300323016266160721288812660063041420300328881266160721407762680063041420300340776268160922
544482630063041420299054448263160223551712630063041420299055171263160223561712640063041420299056171264160327775602640063041420299077560264160327924152650063041420299092415265160424969962650063041420299096996265160424129712660063041420299012971266160721134292660063041420299013429266160721196512660063041420299019651266160721272782660063041420299027278266160721350892660063041420299035089266160721398052680063041420299039805268160922508512680063041420299050851268160922
- SMN 10310292-100 test kits Lot# UDI #
- Amount recalled
- 55,754 kits
Where it was sold
Why it was recalled
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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