Product Wiki · Recalls · Health Canada — Medical Devices

PreciControl Multimaker (2014-12-16) — recall 52616

Health Canada — Medical Devices · Canada · 2015-01-14 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52616
Date of alert
2015-01-14
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/precicontrol-multimaker-2014-1

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