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Catalog Number 1021920000 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The genomic dna sample was sent to grifols laboratory solution for dna sequencing of rh proximal promoter, exons 1-10 and portions of intron 2-3.Two rhce nonfunctional alleles were identified, rhce*ce(488_489del) and rhce*cen.08 (rhce*02.08), both associated with null rhce (non-expression of rhce antigens), which id core xt does not interrogate.Id core xt detected a homozygous functional allele rhce*ce and predicted a false positive c+ and e+.These false positive results obtained by id core xt are considered discrepant results and then a malfunction.This case report is associated with limitations of id core xt assay, as described in the id core xt package insert (sec 1 and 10 assay limitations).
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Event Description
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It was reported that the sample (b)(6), from secretaria da saude do estado do ce, was tested with serology.The test result was negative (c-, e-), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided positive results (c+, e+) with id core xt analysis software v3.0.2.
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Search Alerts/Recalls
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