Kit, Identification, Enterobacteriaceae
Microbiology · 21 CFR 866.2660
Recent MDR events
32 adverse event reports on file
- API 20 NE 25STRIPS+25MEDIAApr 24, 2023MalfunctionBiomérieux Sa9615754-2023-00026
- API 20 E 25STRIPSNov 29, 2022MalfunctionBiomerieux, Sa9615754-2022-00140
- API 20 E 25STRIPSAug 23, 2022MalfunctionBiomerieux, Sa9615754-2022-00101
- API 20 NE 25STRIPS+25MEDIADec 16, 2021MalfunctionBiomérieux Sa9615754-2021-00297
- API® 20 NE 25STRIPS+25MEDIANov 10, 2021MalfunctionBiomérieux Sa9615754-2021-00282
- API 20 NE 25STRIPS+25MEDIANov 7, 2021MalfunctionBiomérieux, Sa9615754-2021-00280
- API RAPID 20 E 25STRIPSOct 27, 2021MalfunctionBiomerieux, Sa9615754-2021-00275
- API 20 NE 25STRIPS+25MEDIA - 20050Aug 19, 2021MalfunctionBiomérieux, Sa9615754-2021-00227
- API 20 E 25STRIPSAug 10, 2021MalfunctionBiomerieux, Sa9615754-2021-00224
- BD BBL CRYSTAL ENTERIC/NONFERMENTER ID SYSTEMApr 13, 2021MalfunctionBecton, Dickinson & Co. (sparks)1119779-2021-00660
Event type breakdown
Recalls
9 recall events for this product code
- Biomerieux IncOpen, ClassifiedJan 4, 2023
API 20 E 25 STRIPS, CATALOG 20100
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0784-2023 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJul 11, 2014
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negat
A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.
Z-2041-2014 · View FDA record ↗ - AdvanDx, Inc.TerminatedJan 2, 2014
AdvanDx Gram-Negative QuickFISH BC.
Kits incompatible with certain fluorescence microscope light sources
Z-0619-2014 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJan 20, 2013
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological te
In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
Z-0699-2013 · View FDA record ↗ - Advandx IncTerminatedOct 22, 2012
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeru
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Z-0112-2013 · View FDA record ↗ - Advandx IncTerminatedOct 22, 2012
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa
Some 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 resulting in a cross-reaction that may produce a red-positive signal
Z-0116-2013 · View FDA record ↗ - AdvanDx, Inc.TerminatedDec 1, 2010
AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnos
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 signal
Z-0491-2011 · View FDA record ↗ - AdvanDx, Inc.TerminatedNov 29, 2010
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia
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 signal.
Z-0490-2011 · View FDA record ↗ - Biomerieux IncTerminatedUnknown
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
There 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.
Z-0422-2022 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
510(k) clearances
49 clearances for this product code
- Miacom Diagnostics GmbHOct 1, 2015
K150031 · hemoFISH Masterpanel
- Advandx, Inc.Jul 21, 2013
K123418 · GRAM-NEGATIVE QUICKFISH BC
- Advandx, Inc.Dec 16, 2010
K101558 · GNR TRAFFIC LIGHT PNA FISH
- Advandx, Inc.Dec 16, 2009
K092236 · E.COLI/P. AERUGINOSA PNA FISH
- Advandx, Inc.Sep 1, 2009
K092393 · EK/P. AERUGINOSA PNA FISH
- Advandx, Inc.Jun 25, 2009
K082068 · E. COLI PNA FISH
- Advandx, Inc.Mar 26, 2009
K081433 · EK/P. AERUGINOSA PNA FISH
- Advandx, Inc.Dec 19, 2008
K081309 · E.COLI/P. AERUGINOSA PNA FISH