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Biotestcell -I 8 and I 11 (2014-06-17)
- Starting date:
- June 17, 2014
- Posting date:
- July 7, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40361
Recalled Products
A) Biotestcell - I 8
B) Biotestcell - I 11
Reason
Using the phenotype profile included in the package when evaluating positive reactions may produce inconsistent or unclear results. Anti-JK(B) and anti-S antibodies may not be identified correctly and this may cause transfusion problems.
Affected products
A) Biotestcell - I 8
Lot or serial number
8421011-00
Model or catalog number
816020100
Companies
- Manufacturer
-
BioRad Medical Diagnostics GMBH
Industriestr.1
Dreieich, Germany, 63303
B) Biotestcell - I 11
Lot or serial number
8421011-00
Model or catalog number
816021100
Companies
- Manufacturer
-
BioRad Medical Diagnostics GMBH
Industriestr.1
Dreieich, Germany, 63303