Model Number BIOPLEX 2200 ANTI-CCP REAGENT PACK |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Bio-rad laboratories has received reports of discrepant results with lot no.301481 from four customers performing lot-to-lot validation against previous lots.Internal testing at bio-rad has demonstrated that lot no.301481 exhibits a reduction in specificity (potential for false positive results).There were no reported adverse event with this lot.However,false positive anti-ccp results could lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment.
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Manufacturer Narrative
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Bio-rad laboratories has received reports of discrepant results with lot no.301481 from four customers performing lot-to-lot validation against previous lots.Internal testing at bio-rad has demonstrated that lot no.301481 exhibits a reduction in specificity.The bias was observed on the low end of the assay range and none of the false positive results observed exceeded 9 u/ml (3x cut-off).This reduction in specificity may lead to an increase in the number of false positives and could lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment.
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Search Alerts/Recalls
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