GNBClass II

Antisera, All Types, Shigella Spp.

Microbiology · 21 CFR 866.3660

MDR events1All time

Recalls3All time

Registered firms8Currently listed

510(k) clearances41All time

Recent MDR events

1 adverse event reports on file

BD DIFCO SHIGELLA ANTISERUM POLY GROUP AMay 25, 2021
MalfunctionLee Laboratories, Inc.1025402-2021-00004

Event type breakdown

Malfunction1

Most-reported manufacturers

Lee Laboratories, Inc.1

Recalls

3 recall events for this product code

Becton Dickinson & Co.
TerminatedAug 16, 2008
Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antise
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
Z-1527-2008 · View FDA record ↗
Becton Dickinson & Co.
TerminatedAug 16, 2008
Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017**
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
Z-1528-2008 · View FDA record ↗
Remel Inc
TerminatedUnknown
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01.
The serum may fail to agglutinate within the specified minimum reaction time.
Z-0290-2018 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

510(k) clearances

41 clearances for this product code