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Biotrin Control Parvovirus B19 IgM (2014-01-07)
- Starting date:
- January 7, 2014
- Posting date:
- February 11, 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-37915
Recalled Products
- Biotrin Control Parvovirus B19 IgM
Reason
Internal investigation confirmed that C of A of Biotrin Control Parvovirus B19 IGM is reporting an incorrect negative control range for the Liaison XL application when used in combination with Biotrin Parvovirus B19 IGM kit.
Affected products
A. Biotrin Control Parvovirus B19 IgM
Lot or serial number
- 158008X
Model or catalog number
- 317081
Companies
- Manufacturer
-
Diasorin Irleand Ltd.
Unit 13/14 Holly Avenue Stillorgan Industrial Park
Blackrock, Dublin
IRELAND