Z-1800-2020Class II

Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A -

Name: Z-1800-2020 Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A -
Creator: Bio-Rad Labs
Published: 2019-04-03
License: https://open.fda.gov/license/

Bio-Rad Labs / initiated 2019-04-03 / Completed

FDA source

Bio-Rad Labs began a recall of 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... on 2019-04-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1800-2020
Classification: Class II
Status: Completed
Initiated: 2019-04-03
Posted: 2020-04-24
Recalling firm: Bio-Rad Labs
Product: 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 code: MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 376 units
Distribution: US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.
Product codes and lots: Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1800-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1800-2020	Class II	Completed	Voluntary: Firm initiated	2020-05-06	2020-04-24

Product code MVM

K042644Class IIAeskulisa Ttg a and Aeskulisa Ttg GAesku, Inc. / cleared 2005-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)