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Catalog Number 1020220034 |
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 07/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The genomic dna sample was sent to (b)(4) laboratory solution for dna sequencing.Dna sequencing interrogated specific sequences: co gene exons 1-4.The co genotype detected two co*a alleles in agreement with id core xt but also a homozygous mutation c.601delg reported as null allele co*01n.06.This mutation is associated with a null colton phenotype co(a-b-), which explains the serology discrepancy.Id core xt reported a predicted coa+ phenotype, but co*01n.06 null allele is associated with a predicted coa- phenotype.This false positive result obtained by id core xt is considered a discrepant result 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 (b)(6) blood transfusion center, was tested with serology.The test result was negative (co null), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided positive results (coa+) with id core xt analysis software v3.0.2.
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Search Alerts/Recalls
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