Coombs lgG and LISS/Coombs for Indirect Antiglobulin Testing (IAT) (2018-04-30)
- Starting date:
- April 30, 2018
- Posting date:
- May 18, 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-66802
Affected products
A. LISS/COOMBS
B. COOMBS ANTI-IGG
Reason
Bio-Rad Laboratoires (Canada) Ltd is issuing this reminder that DiaMed, after an internal study, has noticed an increased level of antibodies of undetermined specificity when using some reagents of the ID-System intended for the screening and identification of irregular antibodies: IDCards Coombs lgG and LISS/Coombs for Indirect Antiglobulin Testing (IAT) associated to Reagent Red Blood Cells.
Affected products
A. LISS/COOMBS
Lot or serial number
50531.14.21
50531.16.01
50531.20.03
50531.21.02
50531.22.01
50531.24.07
50531.27.03
Model or catalog number
004014
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND
B. COOMBS ANTI-IGG
Lot or serial number
50540.01.02
50540.01.05
50540.02.02
50540.04.01
50540.97.01
Model or catalog number
004024
004026
004027
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND