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Cobas IT Middleware
- Starting date:
- February 17, 2017
- Posting date:
- March 10, 2017
- 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-62458
Reason
In specific circumstances, the evaluation of QC Westgard rules can be performed incorrectly. Rules comparing a quality control result with a previous result (or results) can be incorrectly assessed out of sequence. Rules to assess a rising or falling trend in quality control results can also be wrongly evaluated. However, the result released is correct.
Affected products
Cobas IT Middleware
Lot or serial number
All versions
Model or catalog number
- 06498027001
- 06498035001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY