Product Wiki · Recalls · Health Canada — Medical Devices

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT (2016-04-28) — recall 55349

Health Canada — Medical Devices · Canada · 2016-05-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55349
Date of alert
2016-05-16
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: To inform customers of a product recall and reduced expiration dating for select ARCHITECT STAT High Sensitive Troponin-I Reagent lots listed in table 1 of the customer letter and to provide instructions on what actions their laboratory must take. Current in-date reagent lots per table 2 of the customer letter will remain at their current expiration date, therefore no further action is required for those current lots.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/architect-stat-high-sensitive-

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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