Product Wiki · Recalls · Health Canada — Medical Devices

BILD2 and BILIRUBIN TOTAL GEN.3 (2016-07-20) — recall 55719

Health Canada — Medical Devices · Canada · 2016-08-10 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 55719
Date of alert: 2016-08-10
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: This recall/product correction is related to a new drug interference that was identified for Indocynanine Green (ICG) in all direct and total bilirubin tests performed on Roche platforms (cobas c. COBAS INTEGRA, and modular p systems).

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bild2-and-bilirubin-total-gen3

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BILD2 and BILIRUBIN TOTAL GEN.3 (2016-07-20) — recall 55719

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