Health product recall

Cobas Infinity Central Lab (2019-09-26)

Starting date:
September 26, 2019
Posting date:
October 25, 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-71377



Last updated: 2019-10-25

Affected Products

Cobas Infinity Central Lab

Reason

When cobas infinity receives results from an instrument with an alarm code that is not mapped in infinity, if there is a mapped alarm whose first characters (as many characters as the incoming alarm code has) match the received alarm code, cobas infinity incorrectly assigns this mapping to the received alarm.

Affected products

Cobas Infinity Central Lab

Lot or serial number

Software vers.:3.00.00-3.01.02

Model or catalog number

7154003001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY