This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
TPHA Screen (2014-11-12)
- Starting date:
- November 12, 2014
- Posting date:
- November 20, 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-42195
Recalled Products
TPHA Screen
Reason
Immucor is investigating reports of unexpected positive reactions with the TPHA screen assay performed on the Neo and Galileo instruments. The investigation to date has identified a shift in performance with the TPHA screen associated with higher rates of unexpected positive reactions.
Affected products
TPHA Screen
Lot or serial number
- 280304
- 283302
- 283303
- 284383
Model or catalog number
- 0066826
- 0066827
- 0066828
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, PO Box 5625
Norcross
30091-5625
Georgia
UNITED STATES