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Kit, Identification, Enterobacteriaceae

FDA product code JSS · Class 1 · Microbiology

9
Registered devices
32
Adverse events
9
Recalls
49
510(k) clearances

Devices with this code

API® 20 E — BIOMERIEUX SARemel — REMEL, INC.RAPID ID 32 E — BIOMERIEUX SARAPID 20 E™ — BIOMERIEUX SAID indole TDA — BIOMERIEUX SAAPI® 20 NE — BIOMERIEUX SAAPI® 20 E Reagent QC — BIOMERIEUX SARemel — REMEL, INC.REMEL — REMEL, INC.

Recent recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2021-11-09Biomerieux IncThere is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
2014-05-21Becton Dickinson & Co.A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates.
2013-12-11AdvanDx, Inc.Kits incompatible with certain fluorescence microscope light sources
2012-12-13Becton Dickinson & Co.In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentificat
2012-09-14Advandx IncSome strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resu
2012-09-14Advandx IncGNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
2010-10-08AdvanDx, Inc.Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red sign
2010-10-06AdvanDx, Inc.Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signa

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.