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Bilirubin Total Gen.3 (BILT3) (2014-12-11)
- Starting date:
- December 11, 2014
- Posting date:
- January 9, 2015
- 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-43203
Recalled Products
Bilirubin Total Gen.3 (BILT3)
Reason
Information regarding Cyanokit interference on Bilirubin test results was missing in Bilt3 instructions for use.
Affected products
Bilirubin Total Gen.3 (BILT3)
Lot or serial number
All lots.
Model or catalog number
05795320190
05795338190
05795346190
05795397190
05795419190
05795648190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY