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PreciControl Multimaker (2014-12-16)
- Starting date:
- December 16, 2014
- Posting date:
- January 14, 2015
- 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-43233
Recalled Products
PreciControl Multimaker
Reason
During internal stability testing of the reconstituted PreciControl Multimaker of lot 178364, a reduced stability of PIGF became apparent. Whereas the stability claim for all analytes in PreciControl Multimaker is 72 hours at 2-8c, this claim does not apply for PIGF As a consequence, the stability of PIGF has been reduced accordingly in the method sheet of the PreciControl Multimaker. The claim at 2-8c was removed but the frozen and ambient temperature stability remained the same as they are not affected.
Affected products
PreciControl Multimaker
Lot or serial number
From lot # 178364 and higher
Model or catalog number
05341787190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY