This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ADVIA CHEMISTRY 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-60074
Affected Products
- ADVIA CHEMISTRY OPIATE (OP_2) ASSAY
- ADVIA 1200 CHEMISTRY SYSTEM- OPIATE (OP_2) ASSAY2
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
A. ADVIA CHEMISTRY OPIATE (OP_2) ASSAY
Lot or serial number
- 290
- 310
- 320
- 330
- 340
Model or catalog number
- 10378763
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
Companies
B. ADVIA 1200 CHEMISTRY SYSTEM- OPIATE (OP_2) ASSAY2
Lot or serial number
- 290
- 310
- 320
- 330
- 340
Model or catalog number
- 10378763
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES