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Catalog Number 1020220034 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The genomic dna sample was sent to grifols laboratory solutions for dna sequencing.Next generation sequencing interrogated rh genes proximal promoter, exons 1-10, and portions of intron 2-3.The ngs genotype rhce*ce.01(227a), rhce*ce (rhce*02) indicates the presence of a variant rhce:c.227 g>a.This variant is in the exon 2 of rhce gene which is a probe binding site.This variant could affect the detection of the c antigen leading to allele drop-out.Id core xt predicted a c- phenotype, but the serological data indicated a c+ phenotype, attributable to the presence of rare rhce*ce.01(227a) allele.This id core xt false negative result is considered a discrepant result.This limitation is covered by the assay limitations described in the id core xt package insert limitations 1 and 9.5.
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Event Description
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It was reported that the sample (b)(6), from "centro de transfusión de la comunidad valenciana", was tested with serology.The test result was positive (c+), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided negative results (c-) with id core xt analysis software v3.0.2.
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Search Alerts/Recalls
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