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TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOT (2017-09-15)
- Starting date:
- September 15, 2017
- Posting date:
- December 14, 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-65390
Affected products
TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOT
Reason
Biotestcell 1 & 2 contained red blood cells with known phenotypes used to screen for antibodies during immunohematology serologic testing. In a notice issued on September 11, Bio-Rad Medical Diagnostics GmbH reported that the red blood cells in lot 8731011-00 contained in vial 1 (donor #100136) had been declared phenotype Fy(a+ b-), when the correct phenotype was Fy(a+ b+w).
Affected products
TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOT
Lot or serial number
8731011-00
Model or catalog number
816 014 100
Companies
- Manufacturer
-
Bio-Rad Medical Diagnostics GMBH
Industriestr.1
Dreieich