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Roche Hitachi- Gentamicin and GENT2 (Online TDM Gentamicin) (2016-06-01)
- Starting date:
- June 1, 2016
- Posting date:
- June 13, 2016
- 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-58858
Affected products
- ROCHE HITACHI - GENTAMICIN
- ROCHE HITACHI - GENTAMICIN
Reason
The reason for the recall is related to potential increased recovery of patient results (approximately 15-20%) while using the online TDM Gentamicin assay on Roche cobas c 311, c501/c502, c701/c702 or modular p platforms in combination with Preciset TDM I of specific lots. This issue does not affect the Gentamicin reagent used on the COBAS INTEGRA systems.
Affected products
A. ROCHE HITACHI - GENTAMICIN
Lot or serial number
- 11916101
- 61177901
Model or catalog number
- 38000504190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. GENT2 (ONLINE TDM GENTAMICIN)
Lot or serial number
- 11916601
- 11916701
- 61178001
- 61178301
- 61762301
- 61762401
Model or catalog number
- 04490843190
- 05841291190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY