DIMENSION VISTA AND EMIT II OPIATE ASSAYS

Starting date:

August 19, 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-60076

• 
  Reason
• 
  Affected products

Affected Products

1. DIMENSION VISTA SYSTEM - URINE OPIATES SCREEN
2. DIMENSION CLINICAL CHEMISTRY SYSTEM - OPIATES (UOPI)
3. EMIT II PLUS OPIATES ASSAY

Reason

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.

Affected products