FDADecember 21, 2016device
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
What to do
FDA enforcement status: Terminated
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 4234852026-04-01
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