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PreciPath U Plus Control
- Starting date:
- November 3, 2016
- Posting date:
- November 18, 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-61146
Reason
The stability claim of the creatinine value of the Precipath U Plus Control (Catalogue #12149443160) Lot 186345XX was not meeting the manufacturer specifications.
Affected products
PreciPath U Plus Control
Lot or serial number
- 18634502
- 18634503
- 18634504
- 18634505
Model or catalog number
- 12149443160
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY