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Parvovirus B19 IgM DxSelect (2017-10-12)
- Starting date:
- October 12, 2017
- Posting date:
- October 27, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64978
Affected products
Parvovirus B19 IgM DxSelect
Reason
An internal investigation has confirmed that the shelf life of the product does not meet the expiration dating of 24 months. The expiration prediction intervals from each of the product lots cross the limit at 12 months past date of manufacture including a safety margin.
Affected products
Parvovirus B19 IgM DxSelect
Lot or serial number
- X31251
- X32120
- X32894
- X33186
Model or catalog number
EL0100M
Companies
- Manufacturer
-
Diasorin Molecular LLC (also trading as Focus Diagnostics, Inc.)
11331 Valley View Street
Cypress
90630
California
UNITED STATES