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Microbiology devices
418 product codes reviewed by the Microbiology panel. 6,962 510(k) clearances and 1,454 recalls in the FDA data, 54% of those recalls name a 510(k).
94510(k)s in 12 months
68recalls in 12 months
785recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 240 | 6 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 78 | 0 |
| MDB | System, Blood Culturing | 76 | 0 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 56 | 0 |
| JTN | Susceptibility Test Discs, Antimicrobial | 47 | 1 |
| JTR | Kit, Quality Control For Culture Media | 46 | 4 |
| LTW | Susceptibility Test Cards, Antimicrobial | 39 | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 34 | 0 |
| JSG | Culture Media, Non-Selective And Non-Differential | 29 | 0 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 25 | 0 |
| JSI | Culture Media, Selective And Differential | 24 | 0 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 24 | 5 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 21 | 0 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 20 | 4 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 20 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 2 | 9 | 3 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 2 | 4 | 6 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | 3 | 5 |
| JTN | Susceptibility Test Discs, Antimicrobial | 2 | 6 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 2 | 4 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 2 | 6 | 0 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 2 | 0 | 6 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 2 | 5 | 0 |
| JTR | Kit, Quality Control For Culture Media | 1 | 0 | 4 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 2 | 4 | 0 |
| LSE | Epstein-Barr Virus, Other | 1 | 2 | 1 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 | 1 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 2 | 0 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | 3 | 0 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 2 | 3 | 0 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 2 | 3 | 0 |
| SAN | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | 2 | 3 | 0 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 1 | 1 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 2 | 0 |
| KZJ | Device, Gas Generating | 1 | 0 | 2 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 0 | 2 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 2 | 2 | 0 |
| LYR | Helicobacter Pylori | 1 | 0 | 2 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 2 | 2 | 0 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 2 | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 2 | 1 | 1 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | 2 | 0 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | 2 | 0 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | 2 | 0 |
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 2 | 0 | 2 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 2 | 2 | 0 |
| QVP | Sars-Cov-2 Serology Test | 2 | 2 | 0 |
| GPN | Antiserum, Typhus Fever | 1 | 0 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 | 0 |
| GRM | Antisera, All Groups, Salmonella Spp. | 2 | 0 | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 2 | 0 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 0 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 | 0 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 0 | 1 |
| JTQ | Bath, Incubators/Water, All | 1 | 0 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 0 | 1 |
| JWZ | Kit, Screening, Trichomonas | 1 | 0 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 1 | 0 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | 0 | 1 |
| LHK | Antigen, Id, Candida Albicans | 2 | 0 | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 | 0 | 1 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | 0 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 0 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 | 0 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 2 | 1 | 0 |
| LQG | Dna-Reagents, Mycoplasma Spp. | 1 | 0 | 1 |
| LQL | Gram Positive Identification Panel | 1 | 0 | 1 |
| LRF | Candida Spp., Direct Antigen, Id | 2 | 0 | 1 |
| LTW | Susceptibility Test Cards, Antimicrobial | 2 | 0 | 1 |
| MDB | System, Blood Culturing | 1 | 1 | 0 |
| MHI | Giardia Spp. | 2 | 0 | 1 |
| NGZ | Susceptibility Test Plate, Antifungal | 2 | 0 | 1 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 2 | 1 | 0 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | 0 | 1 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | 0 | 1 |
| OZZ | Bordetella Pertussis Dna Assay System | 2 | 1 | 0 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 2 | 1 | 0 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | 1 | 0 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 2 | 0 | 1 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 2 | 1 | 0 |
| PPU | Microbial Colony Image Assessment System | 2 | 1 | 0 |
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | 2 | 1 | 0 |
| QDP | Respiratory Panel | 2 | 0 | 1 |
| QPS | Immunoassay For Host Biomarkers Of Infection | 2 | 1 | 0 |
| QUT | Deformability Cytometry For Sepsis Risk Assessment | 2 | 1 | 0 |
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 2 | 1 | 0 |
| QXA | Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection | 2 | 1 | 0 |
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | 2 | 1 | 0 |
| SIA | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test | 2 | 1 | 0 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: BioFire Joint Infection (JI) Panel
Generic Name: BioFire Joint Infection (JI) Panel
Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit)
Software Version: N/A
Product Desc Open, Classified |
QSN | None listed |
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel
Generic Name: FilmArray Pneumonia Panel
Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification k Open, Classified |
QDP | K243222 |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-306. Catalog Number: 449292. Open, Classified |
LON | K181665 |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-312. Catalog Number: 449082. Open, Classified |
LON | K181665 |
| Sep 18, 2026 | Biomerieux Inc VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 Open, Classified |
LON | None listed |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF(s):L2kSY2/10489085; L2KSY6/10488319
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF:L2KSY2(D)/10471981
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Aug 12, 2026 | BioFire Diagnostics, LLC BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742
UDI code: 00815381020529
PCR-based multiplexed nucleic acid test, in vitro diagnostic Open, Classified |
QOF | None listed |
| Aug 7, 2026 | Remel Europe Ltd. Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics Open, Classified |
GTJ | None listed |
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instrument
- B1018-2 Open, Classified |
LON | K201405 |
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instr Open, Classified |
LON | K201405 |
| Aug 5, 2026 | Hardy Diagnostics HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435
HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the suscepti Open, Classified |
JTN | K253105 |
| Jul 9, 2026 | Biomerieux Inc VITEK 2 AST-N447 TEST KIT
Product reference 424620 Open, Classified |
LON | None listed |
| Jun 30, 2026 | Remel, Inc GC Agar Base (150mm) 10/PK R04030;
GC Agar Base (100mm) 10/PK R01460 Open, Classified |
JTY | K954986 |
| May 12, 2026 | Quidel Corporation QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. Open, Classified |
GTY | K011097 |
| May 6, 2026 | BioFire Diagnostics, LLC BioFire Joint Infection (JI) Panel
REF: RFIT-ASY-0138, 30 test Kit. Open, Classified |
QSN | None listed |
| May 6, 2026 | BioFire Diagnostics, LLC Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485 Open, Classified |
QOF | K232954 |
| Apr 29, 2026 | Becton Dickinson & Co. BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use Open, Classified |
KZJ | None listed |
| Apr 29, 2026 | Becton Dickinson & Co. BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use Open, Classified |
KZJ | None listed |
| Apr 22, 2026 | Remel Europe Ltd. Oxoid Agglutinating Sera, Salmonella 9-0
R30957301 Open, Classified |
GRM | None listed |
| Apr 10, 2026 | Remel, Inc Yeastone Broth, 11ML, 10/BOX
YY3462 Open, Classified |
NGZ | K090968 |
| Apr 8, 2026 | Beckman Coulter, Inc. MicroScan Neg Multidrug Resistant MIC 1 REF C32368
UDI-DI code: 15099590720568
Intended Use- For use with MicroScan Dried Gram Negative
MIC/Combo Panels and Dried Gram Negative Breakpoint Combo
Panel Open, Classified |
LTT | None listed |
| Apr 3, 2026 | Beckman Coulter, Inc. MicroScan Neg MIC 3J REF C54814 Open, Classified |
LTT | None listed |
| Apr 2, 2026 | Oxoid Australia Pty Limited OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem Open, Classified |
LQL | None listed |
| Mar 27, 2026 | BD KIESTRA LAB AUTOMATION BD Kiestra" ReadA;
Catalog No.: 446948. Open, Classified |
JTQ | None listed |
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