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BILD2 and BILIRUBIN TOTAL GEN.3 (2016-07-20)
- Starting date:
- July 20, 2016
- Posting date:
- August 10, 2016
- 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-59742
Affected products
A. BILD2 (DIRECT BILIRUBIN GEN.2)
B. BILIRUBIN TOTAL GEN.3 (BILT3)
Reason
This recall/product correction is related to a new drug interference that was identified for Indocynanine Green (ICG) in all direct and total bilirubin tests performed on Roche platforms (cobas c. COBAS INTEGRA, and modular p systems).
Affected products
A. BILD2 (DIRECT BILIRUBIN GEN.2)
Lot or serial number
All lots
Model or catalog number
- 05168384190
- 05589037190
- 05589061190
- 05589134190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. 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
Sandhoferstrasse 116
Mannheim
68305
GERMANY