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DIMENSION VISTA AND EMIT II OPIATE ASSAYS — recall 55730

Health Canada — Medical Devices · Canada · 2016-08-19 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55730
Date of alert
2016-08-19
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: Siemens investigation confirmed that the introduction of a new SYVA polyclonal antibody lot (G1) for use in the dimension urine opiates screen has resulted in an alteration of specificity for Levallorphan, Levorphanol, Nalorphine and Oxycodone at the 300 and 2000 NG/ml cutoff concentration. As a result in the change in sensitivity to the cross reactant, the claims for these compounds are no longer accurate for either the 300 or 2000 NG/ml cutoff as stated within the instructions for use (IFU). Further investigation confirmed that SYVA, Beckman Coulter and Advia Chemistry Opiate reagents are impacted as well due to a common raw material used in the assays.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-and-emit-ii-op

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