Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA (2019-04-10)

Starting date:

April 10, 2019

Posting date:

May 10, 2019

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-69866

Last updated: 2019-05-10

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  Reason
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  Affected products

Affected Products

Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA

Reason

Elevated lot-to-lot bias were observed by comparing a new EIA anti-Q15tTG IgA autoimmune lot (catalog# 4252260, lot# 18200a) to a previous lot (catalog# 4252260, lot# 18010a). This observation has been confirmed by recent tests by Bio-Rad using internal test samples.

Affected products