Manual Antimicrobial Susceptibility Test Systems
Microbiology · 21 CFR 866.1640
Recent MDR events
153 adverse event reports on file
- SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATEDec 5, 2024MalfunctionTrek Diagnostic Systems, Ltd.MW5163355
- DAPTOMYCIN DPC 256 US S30 - 412323Nov 2, 2023MalfunctionBiomerieux, Sa9615754-2023-00047
- DAPTOMYCIN DPC 256 US S30 - 412323Nov 2, 2023MalfunctionBiomerieux, Sa9615754-2023-00048
- DAPTOMYCIN DPC 256 US S30 - 412323Nov 2, 2023MalfunctionBiomerieux, Sa9615754-2023-00046
- DAPTOMYCIN DPC 256 US S30 - 412323Nov 2, 2023MalfunctionBiomerieux, Sa9615754-2023-00049
- DAPTOMYCIN DPC 256 US S30®Nov 2, 2023MalfunctionBiomerieux, Sa9615754-2023-00050
- DAPTOMYCIN DPC 256 US S30®Oct 25, 2023MalfunctionBiomerieux, Sa9615754-2023-00044
- BENZYLPENICIL PG 32 WW S30 - 412265Jul 18, 2023MalfunctionBiomérieux Sa9615754-2023-00034
- TRIM/SULFA 1/19 TS 32 WW S30 - 412481Jul 17, 2023MalfunctionBiomerieux Sa9615754-2023-00033
- ETEST® VANCOMYCIN (VA)Jan 25, 2023MalfunctionBiomérieux Sa9615754-2023-00003
Event type breakdown
Recalls
78 recall events for this product code
- Remel, IncOpen, ClassifiedJun 11, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Product may have an off color affecting perfomance
Z-1947-2025 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0817-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0818-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0819-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0820-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0821-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0822-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0823-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0825-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0826-2023 · View FDA record ↗
Registered firms
282 firms currently registered for this product code
510(k) clearances
441 clearances for this product code
- bioMérieux SAApr 21, 2026
K260447 · ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- Liofilchem s.r.l.Apr 17, 2026
K260696 · MTS Gepotidacin 0.016-256 µg/mL
- Liofilchem s.r.l.Oct 2, 2025
K252114 · MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- Thermo Fisher ScientificSep 25, 2025
K252062 · The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- Thermo Fisher ScientificSep 5, 2025
K250575 · The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- Thermo Fisher ScientificAug 28, 2025
K252014 · The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- Liofilchem s.r.l.Aug 20, 2025
K251580 · MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
- Thermo Fisher ScientificJun 30, 2025
K250990 · The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
PMA approvals
1 premarket approvals for this product code