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TRIGL (TRIGLYCERIDES) FOR COBAS C701 ANALYZER (2016-05-06)
- Starting date:
- May 6, 2016
- Posting date:
- May 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-58524
Affected products
- TRIGL (TRIGLYCERIDES) FOR COBAS C701 ANALYZER
Reason
The manufacturer has identified during an internal investigation on a unique customer complaint, that a change in the Cobas C701-702 application prozone limit check was required for the triglycerides assay to address a potential for low results without the expected flag. The application package has been modified and has been provided accordingly to add the new prozone limit check.
Affected products
A. TRIGL (TRIGLYCERIDES) FOR COBAS C701 ANALYZER
Lot or serial number
11932001
12552901
14854801
61022901
61287501
61479601
61900301
Model or catalog number
5171407190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY