Product Wiki · Recalls · Health Canada — Medical Devices

G-6-PDH Deficient and Normal Control (2019-03-26) — recall 59424

Health Canada — Medical Devices · Canada · 2019-04-09 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
59424
Date of alert
2019-04-09
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Randox is conducting a Field Safety Corrective Action for G6PDH Deficient and Normal Controls for the lots specified in the Field Safety Notice . The target values and ranges are incorrect and are re-assigned. In addition customers are reminded to follow the assay protocol for G6PDH in the Instructions for Use (PD410) and to use the quoted calibration factor to ensure accuracy of results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/g-6-pdh-deficient-and-normal-c

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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