Product Wiki · Recalls · Health Canada — Medical Devices

ARCHITECT System - Creatine Kinase Assay (2018-07-20) — recall 58223

Health Canada — Medical Devices · Canada · 2018-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58223
Date of alert
2018-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The purpose of this is to inform customers of a product recall for the ARCHITECT Creatine Kinase (CK) reagent and to provide instructions on what actions must be taken. Abbott has identified a stability issue that may lead to the following issues. Error Code 1054 ""Unable to calculate results, Reaction Check Failure. Quality control (QC) results out of range low. A potential delay may exist in the reporting of patient results due to quality control values falling outside of expected ranges and the generation of error code 1054. Internal testing on patient samples showed no atypical bias for the impacted reagent lots, therefore if quality controls are in range, patient results are not impacted.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/architect-system-creatine-kina

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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