Health product recall

cobas IT 1000 Software (2019-08-22)

Starting date:
August 22, 2019
Posting date:
September 6, 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-70907

Last updated: 2019-09-06

Affected Products

cobas IT 1000 Software

Reason

Results displayed in cobas IT 1000 in the "Results & Patients > Result Query" screen coming from the radiometer ABL90 instrument could have multiple result values for the same patient ID, which originate from both the patient sample and calibration results.

Affected products

cobas IT 1000 Software

Lot or serial number

with ABL90 driver v 2.0.0

Model or catalog number

4420306001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY