Health product recall

Cobas Infinity Central Lab (2019-09-26)

Starting date:
September 26, 2019
Posting date:
November 1, 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-71445



Last updated: 2019-11-01

Affected Products

Cobas Infinity Central Lab

Reason

Customers running cobas Infinity 3.00.00 to 3.01.02 are potentially affected by a software issue related to rule engine module. When a rule with activation mode "when being called by another rule" is edited, other unrelated rules actions might be modified.

Affected products

Cobas Infinity Central Lab

Lot or serial number

Software version: 3.00.00-3.01.02

Model or catalog number

7154003001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY