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Profile-II A (2014-10-20)
- Starting date:
- October 20, 2014
- Posting date:
- November 4, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41999
Recalled Products
Profile-II A
Reason
The recall arose out of one complaint received on September 22, 2014 which indicated that the control (CTRL) line for the oxycodone (OXY) test is not aligned with the marked ctrl position on the device top. When using lot 101, P/N 601681 Profile-II A 7-panel drugs of abuse screening devices.
Affected products
Profile-II A
Lot or serial number
LOT #101
Model or catalog number
601681
Companies
- Manufacturer
-
Medtox Diagnostics
1238 Anthony Road
Burlington
27215
North Carolina
UNITED STATES