Manual Antimicrobial Susceptibility Test Systems
FDA adverse event reports and recall history for manual antimicrobial susceptibility test systems (product code JWY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 153
- Deaths
- 0
- Injuries
- 1
- Malfunctions
- 151
Reports per year
Source: FDA adverse event reports by year received, 1997–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-06-11Open, ClassifiedUnder Investigation by firm
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
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
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
- 2023-01-04Open, ClassifiedStorage
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
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-04Open, ClassifiedStorage
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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