Recall Z-1800-2020 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Bio-Rad Labs
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.
| Date | Apr 3, 2019 |
| Status | Completed |
| Reason | 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. |
| 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 |
| Quantity | 376 units |
| Distribution | US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042644 | AESKULISA TTG A AND AESKULISA TTG G Aesku, Inc., Jun 1, 2005 |