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Liaison EBV IgM (2015-08-04)
- Starting date:
- August 4, 2015
- Posting date:
- October 22, 2015
- 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-55474
Affected Products
Liaison EBV IgM
Reason
Recall initiated due to observed trend which may cause the potential for false positive results. Internal testing confirmed the kit performance is meeting performance claims. EBV-IgM (Esptein-Barr Virus Immunoglobulin) results should not be used alone but in conjunction with other EBV serological markers to determine disease state.
Affected products
Liaison EBV IgM
Lot or serial number
028036X
Model or catalog number
310500
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Avenue, P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES