Reported Sep 14, 2016 · Terminated
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
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; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
- Lot codes and dates
- SMN 10310292 - 100 test kits Lot# UDI#24
4077626800630414203003407762681609225353526800630414203003535352681609226701526900630414203003670152691611247233526900630414203003723352691611
11 70205 19110272 0063041420300319110272170418 27655272 0063041420300327655272170418 SMN 10310293- 500 test kits Lot#8215627000630414203003821562701612298750427000630414203003875042701612299329827100630414203003932982711702055702271006304142030030570227117020517339271006304142030031733927
UDI#398052685085126860225269715442698108527086551270935052717329271162522722468927233327272
00630414202990398052681609220063041420299050851268160922006304142029906022526916112400630414202990715442691611240063041420299081085270161229006304142029908655127016122900630414202990935052711702050063041420299007329271170205006304142029901625227217041800630414202990246892721704180063041420299033327272170418
- SMN 10310292 - 100 test kits Lot# UDI#
Where it was sold
- Nationwide
- GA
Why it was recalled
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
This product could cause temporary or reversible health problems — stop using it.
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