Health product recall

COBAS 6800, 8800 (2019-06-13)

Starting date:
June 13, 2019
Posting date:
July 19, 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-70439

Last updated: 2019-07-19

Affected Products

A. COBAS 6800
B. COBAS 8800

Reason

The processing transfer heads can, in certain conditions, leak on the processing module deck, heating station and separation station, which could cause invalid results, false positives or over-quantified results as a consequence of cross contamination of samples.

Affected products

A. COBAS 6800

Lot or serial number

All lots.

Model or catalog number

5524245001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY

B. COBAS 8800

Lot or serial number

All lots.

Model or catalog number

5412722001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY