Bio-Rad Labs: Medical Device Recall in 2020 - (Recall #: Z-1800-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

Product Classification:

Class II

Date Initiated: April 3, 2019

Date Posted: May 6, 2020

Recall Number: Z-1800-2020

Event ID: 85074

Reason for Recall:

An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

Status: Completed

Product Quantity: 376 units

Code Information:

Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.

Distribution Pattern:

US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated