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U.S. Department of Health and Human Services

Class 2 Device Recall AntiTissue Transglutaminase (tTg) IgA Test

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 Class 2 Device Recall AntiTissue Transglutaminase (tTg) IgA Testsee related information
Date Initiated by FirmApril 03, 2019
Create DateApril 24, 2020
Recall Status1 Completed
Recall NumberZ-1800-2020
Recall Event ID 85074
510(K)NumberK042644 
Product Classification Autoantibodies, endomysial(tissue transglutaminase) - Product Code MVM
ProductAutoimmune 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 Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.
FEI Number 1000135116
Recalling Firm/
Manufacturer		 Bio-Rad Labs
5500 E 2nd St
Benicia CA 94510-1020
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 RA_CID@bio-rad.com. Customers were instructed to contact their local Bio-Rad Technical Support with any questions regarding the Field Action Notification.
Quantity in Commerce376 units
DistributionUS Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = MVM
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