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
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
ALB2 (Albumin Gen.2) for Cobas C701 Analyzer
Lot or serial number
36133801
Model or catalog number
5166861190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY