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Elecsys HIV Combi PT (2014-01-29)
- Starting date:
- January 29, 2014
- Posting date:
- April 14, 2014
- 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-38987
Recalled Products
Elecsys HIV Combi PT
Reason
Manufacturer has identified through customers complaints a possibility that the Elecsys HIV Combi PT may show a calibration signal shift in the control, PC HIV level 1, and may read out of range (greater than 3SD).
Affected products
Elecsys HIV Combi PT
Lot or serial number
171983
172659
173326
175019
Model or catalog number
05390095190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY