Health product recall

cobas IT middleware (2019-06-12)

Starting date:
June 12, 2019
Posting date:
June 28, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70325

Last updated: 2019-06-28

Affected Products

cobas IT middleware

Reason

The cobas IT middleware of software version 1.10.00 using the multi-level QC configuration may allow patient results to be released with invalid QC results. This affect the evaluation of the QC lock-status (QC error) when more than one level is configured to be used.

Affected products

cobas IT middleware

Lot or serial number

Software version: 1.10.00 only

Model or catalog number

6498027001
6498035001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY