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TPHA Screen Test Cells
- Starting date:
- May 18, 2017
- Posting date:
- June 12, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63586
Reason
Immucor, Inc. is issuing this medical device recall regarding the stability of the TPHA screen test cells, lot 280006. A review of post-release testing demonstrated this lot of TPHA screen test cells had a decrease in sensitivity for detection of antibodies to treponema pallidum over the product's shelf life.
Affected products
TPHA Screen Test Cells
Lot or serial number
280006
Model or catalog number
0066826
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES