Panocell-10, Ficin Treated (2018-01-30)
- Starting date:
- January 30, 2018
- Posting date:
- February 9, 2018
- 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-65944
Affected products
Panocell–10, Ficin Treated
Reason
Immucor has received reports that red blood cells treated with these Ficin solution lots may fail to meet the 3 to 4+ result required when confirming Ficin treatment with the Ficin control. Weak reactions obtained with the control test require repeat of the pre-modification procedure.
Affected products
Panocell-10, Ficin Treated
Lot or serial number
- 38310-E
- 40332-E
- 42355-E
- 46089-E
- 48110-E
- 50135-E
Model or catalog number
0002385
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES