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Capture-R Ready-Screen (3)
- Starting date:
- August 1, 2017
- Posting date:
- September 5, 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-64390
Reason
Immucor, Inc. is issuing a product recall notification for Capture-R Ready-Screen (3), Lot R889. Lot R889 demonstrates an increased trend of complaints for unexpected negative/false-negative antibody screen results. In post-release testing, the product continues to demonstrate appropriate positive reactivity with antigen-positive test wells.
Affected products
Capture-R Ready-Screen (3)
Lot or serial number
DR16J18096
Model or catalog number
0066803
0066813
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES