Product Wiki · Recalls · Health Canada — Medical Devices

COBAS INTEGRA TINA-QUANT SOLUBLE TRANSFERRIN RECE (2015-07-03) — recall 53893

Health Canada — Medical Devices · Canada · 2015-08-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53893
Date of alert
2015-08-10
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: Roche received a customer complaint regarding elevated imprecision and too high recovery of STFR control set level 1 and DUP alarms during calibration with the reagent TQ Soluble Transferrin Receptor (STFR). The issue of elevated imprecision was confirmed by internal investigations on lot #606449 on Cobas C501 showed elevated imprecision of up to 8.9%. The other current reagent lots are not affected by this issue
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-integra-tina-quant-solub

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