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BIOTESTCELL -I11 (2015-06-05)
- Starting date:
- June 5, 2015
- Posting date:
- July 21, 2015
- 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-54294
Affected Products
A.BIOTESTCELL -I11
Reason
The phenotypic profile of lots of affected Biotestcell-l11 states that the cells contained in vial number 10 are positive for antigen M. Following an investigation into a complaint, it was confirmed that the cells were M-negative. It is impossible to identify anti-M antibodies using the two affected lots.
Affected products
A.BIOTESTCELL -I11
Lot or serial number
- 2515011-00
- 8515011-00
Model or catalog number
- 816 021
- 816021100
Companies
- Manufacturer
-
BioRad Medical Diagnostics GMBH
INDUSTRIESTR.1
DREIEICH
63303
GERMANY