COBAS INFINITY CENTRAL LAB (2021-06-30)
- Starting date:
- June 30, 2021
- Posting date:
- July 16, 2021
- 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-76023
Last updated:
2021-07-15
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.
Affected products
COBAS INFINITY CENTRAL LAB
Lot or serial number
SW versions 3.01.03 to 3.03.03
Model or catalog number
7154003001
9180443001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY