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Online DAT Amphetamines II for Cobas Integra
- Starting date:
- June 20, 2012
- Posting date:
- July 9, 2012
- 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-26341
Recalled Products
- Online DAT Amphetamines II for Cobas Integra
Reason
Patient and control sample recovery may be decreased with the online dat amphetamines II reagent (Lot number 654236-01) when used on the Cobas Integra 400 and 800 Series Analysers. The affected lot shows reduced D-Amphetamine cross-reactivity for higner concentrated D-Amphetamine samples.
Affected products
A. Online DAT Amphetamines II for Cobas Integra
Lot or serial number
- 65423601
Model or catalog number
- 4512936190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoffer Strasse 116
Mannheim
68305
GERMANY