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Cobas TaqScreen MPX Negative Control
- Starting date:
- March 14, 2013
- Posting date:
- April 30, 2013
- 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-28901
Recalled Products
- Cobas TaqScreen MPX Negative Control
Reason
Negative control failure that may be encountered when using the Cobas TaqScreen MPX test (donor screening) CE mark. The data indicates that the level of target being detected in the normal human plasma (NHP) is 1 iu/mL and that the target is Hepatitis B virus (HBV).
Affected products
A. Cobas TaqScreen MPX Negative Control
Lot or serial number
- 087276
- 089893
Model or catalog number
- 04626290190
Companies
- Manufacturer
-
Roche Molecular Systems, Inc.
1080 US Highway 202
Branchburg
83517
New Jersey
UNITED STATES