Product Wiki · Recalls · Health Canada — Medical Devices

Allset+T Gold HLA ABC Low Resolution (2014-03-11) — recall 51348

Health Canada — Medical Devices · Canada · 2014-04-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51348
Date of alert
2014-04-04
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: When using 54340D Allset+ Gold HLA ABC Low Resolution kit lot number 038 1249868, Primer mix PM085C has been shown to produce a weak false positive reaction of correct size (420 base pair PCR Amplicon) in the presence of samples containing C*04 homozygote allele(s). Primer mix PM085C can be found in lane 78. As a result of the false positive reaction, samples containing two C*04 alleles could produce a mistype or no-type result depending on the reaction pattern corresponding to the full ABC HLA typing.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/allsett-gold-hla-abc-low-resol

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