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PreciControl Varia
- Starting date:
- December 8, 2016
- Posting date:
- January 18, 2017
- 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-61810
Reason
The barcode and value sheet of the PreciControl Varia of lot number 18928501 contained an erroneous parathyroid hormone (PTH) target value when used on Cobas e411 Immunoassay Analyzer for control level 2.
Affected products
PreciControl Varia
Lot or serial number
18928501
Model or catalog number
05618860190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY