COBAS INFINITY CENTRAL LAB (2021-06-30) | Recall Monitor

COBAS INFINITY CENTRAL LAB (2021-06-30)
Health Products
Jun 30th, 2021 @ 12:00 AM

Basic Details

Issue: Medical Devices
Category: Medical Device
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Hazard classification: Type II
Alert type: Medical Device Recall

Products

Lot or serial numberCompaniesBrand nameModel or catalog number
SW versions 3.01.03 to 3.03.03
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
COBAS INFINITY CENTRAL LAB7154003001

Introduction

Affected Products

COBAS INFINITY CENTRAL LAB

Reason

Under certain circumstances, the result of cobas e flow tests could be replaced by an automatic result. This automatic result could be released and interpreted as a positive/negative result.

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