Health product recall

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