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

• 
  Reason
• 
  Affected products

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