GMZClass I

Antigens, All Types, Escherichia Coli

Microbiology · 21 CFR 866.3255

MDR events1All time

Recalls2All time

Registered firms16Currently listed

510(k) clearances14All time

Recent MDR events

1 adverse event reports on file

IMMUNOCARD STAT! EHECSep 29, 2017
DeathMeridian Bioscience, Inc.1524213-2017-00001

Event type breakdown

Death1

Most-reported manufacturers

Meridian Bioscience, Inc.1

Recalls

2 recall events for this product code

Hardy Media Inc Dba Hardy Diag
TerminatedOct 27, 2006
HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
Performance failure; the product is failing to show pigment development for E. coli 0157.
Z-0078-2007 · View FDA record ↗
Remel, Inc.
TerminatedAug 17, 2004
ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxin
A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
Z-1373-04 · View FDA record ↗

Registered firms

16 firms currently registered for this product code

510(k) clearances

14 clearances for this product code