ALB2 (Albumin Gen.2) for Cobas C701 Analyzer (2019-09-11)

Starting date:

September 11, 2019

Posting date:

November 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71587

Last updated: 2019-11-15

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  Reason
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  Affected products

Affected Products

ALB2 (Albumin Gen.2) for Cobas C701 Analyzer

Reason

Calibration and Quality Control failures may occur while using the Albumin of lot 33962301 and Total Bilirubin of lot 36133801 on cobas c701/702 instruments leading to underestimation of albumin and total bilirubin in serum/plasma.

Affected products