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