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MICRO SSP ALLELE SPECIFIC HLA CLASS I DNA TYPING TRAY-A*02… — recall 53454

Health Canada — Medical Devices · Canada · 2015-04-02 · Type II

As described by Health Canada — Medical Devices: MICRO SSP ALLELE SPECIFIC HLA CLASS I DNA TYPING TRAY-A*02 (2015-02-23)

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Agency
Health Canada — Medical Devices
Recall identifier
53454
Date of alert
2015-04-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: One Lambda, Inc., part of Thermofisher Scientific, is conducting a correction of the micro SSP allele specific HLA Class I DNA typing TRAY-A*02. The primer sets in well 3B and 5C are incorrect which may cause a mistype. Any A*02:01, A*68:02 sample will generate a positive band in well 3B and a negative band in well 5C. As a result, the HLA fusion software will display an A*02:75, A*68:01/23/59n typing.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/micro-ssp-allele-specific-hla-

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