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ID-DIAPIANEL (P) (2016-07-04)
- Starting date:
- July 4, 2016
- Posting date:
- July 19, 2016
- 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-59402
Affected products
- ID-DIAPANEL
- ID-DIAPANEL P
Reason
DiaPanel and DiaPanel P contain red blood cells with known phenotypes that are used to identify antibodies in immunohematology serology studies. A typographical error was found on the phenotype profile provided with both the regular and papain-treated panels. Diamed was notified by a client who tested a patient who developed an anti-kp(a) reaction and whose cell 7 was not positive. It was confirmed that the donor, 890147, was not kp(a+).
Affected products
A. ID-DIAPANEL
Lot or serial number
45161.85.1
Model or catalog number
4114
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
B. ID-DIAPANEL P
Lot or serial number
45171.85.1
Model or catalog number
4214
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND