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Cytomegalovirus (CMV) IGG Product Code: 2325200 (2013-09-06)
- Starting date:
- September 6, 2013
- Posting date:
- November 7, 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-36643
Recalled Products
Cytomegalovirus (CMV) IGG Product Code: 2325200
Reason
The positive control runs high and out of range. This will make the analysis invalid. Additional testing has re-ranged and widened the control value to 2.2-4.6.
Affected products
Cytomegalovirus (CMV) IGG Product Code: 2325200
Lot or serial number
- 557
Model or catalog number
- 2325200
Companies
- Manufacturer
-
Trinity Biotech USA
2823 Girls Rd.
P.O. Box 1059
Jamestown
14701
New York
UNITED STATES