Health product recall

Cobas IT Middleware (2019-07-26)

Starting date:
July 26, 2019
Posting date:
August 16, 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-70735



Last updated: 2019-08-16

Affected Products

Cobas IT Middleware

Reason

A situation was identified describing a potential situation for the cobas IT Middleware (cat # 06498027001 and 06498035001, SW versions 1.09.00, 1.09.01 And 1.10.00) To have patient results that could be sent without QC validation in very specific conditions.

Affected products

Cobas IT Middleware

Lot or serial number

software version: 1.09.00

software version: 1.09.01

software version: 1.10.00

Model or catalog number

6498027001

6498035001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY