MVMClass II

Autoantibodies, Endomysial(tissue Transglutaminase)

Immunology · 21 CFR 866.5660

MDR events2All time

Recalls1All time

Registered firms51Currently listed

510(k) clearances40All time

Recent MDR events

2 adverse event reports on file

DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELEJun 10, 2024
MalfunctionSt. Jude Medical / Abbott MedicalMW5156134
QUANTA FLASH H-TTG IGAMay 19, 2017
InjuryInova Diagnostics, IncMW5069924

Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

Inova Diagnostics, Inc1 St. Jude Medical / Abbott Medical1

Recalls

1 recall events for this product code

Bio-Rad Labs
CompletedUnknown
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
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.
Z-1800-2020 · View FDA record ↗

Registered firms

51 firms currently registered for this product code

510(k) clearances

40 clearances for this product code