Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test recallZ-1800-2020 · Bio-Rad Labs · initiated Apr 3, 2019
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bio-Rad Labs or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 3, 2019, a Field Action Letter with response form was sent to U.S. Customers via Fed Ex courier while subsidiaries were notified via email. Customers were instructed to immediately discontinue further use of, and dispose of, any unused product according to local waste management procedures. Customers were requested to complete the attached customer response form as an acknowledgement with information including: account name, customer account number, contact name and title, address, and telephone number. Customers were instructed to check off the statement acknowledging awareness of the field action and that they had proceeded according to instructions issued by Bio-Rad. Completed forms were to be returned to [email protected]. Customers were instructed to contact their local Bio-Rad Technical Support with any questions regarding the Field Action Notification.
Recall details
- Recall number
- Z-1800-2020
- Status
- Completed
- Initiated by the company
- Apr 3, 2019
- Recalling firm
- Bio-Rad Labs
- Quantity
- 376 units
- Product code
- MVM
- FDA submissions
- K042644
- Distribution
- US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.
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.
Code information (models, lots, serial numbers)
Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Autoimmune EIA 425-2260Bio-Rad Laboratories, Inc. · Autoantibodies, endomysial(tissue transglutaminase)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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