Product Wiki · Recalls · Health Canada — Medical Devices

Phadia 250 Instrument (including software) (2017-11-29) — recall 57713

Health Canada — Medical Devices · Canada · 2018-01-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57713
Date of alert
2018-01-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Erroneous results may occur as a result of a software issue when specific conditions occur with the Phadia 250. The issue can occur with all versions of the Phadia Prime Software up to and including version 2.1.4. The issue will cause software to disregard default dilution factors for rejected samples, when using the "ok to all" function for retesting of samples if specific criteria are met.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/phadia-250-instrument-includin

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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