Anti-D (Monoclonal Blend) (2020-04-16)

Starting date:

April 16, 2020

Posting date:

May 15, 2020

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-73081

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

Anti-D (Monoclonal Blend)

Reason

Immucor has received reports, from customers, of weaker than expected and unexpected negative reactivity at the immediate-spin phase of testing using Anti-D (Monoclonal Blend) blood grouping reagent. In their investigation, post-release testing has shown a decrease in the potency of the IGM antibody component, GAMA401. The IGG antibody component, F8D8 is not affected and continues to meet specifications for potency and reactivity.

Affected products