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Susceptibility Test Cards, Antimicrobial
FDA product code LTW · Class 2 · Microbiology
76
Registered devices
10
Adverse events
39
Recalls
16
510(k) clearances
Devices with this code
Selux AST Gram Negative Panel — Selux Diagnostics, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.Selux Seaparator Reagent Kit — Selux Diagnostics, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.VITEK® 2 0,45% Sodium Chloride Diluent — BIOMERIEUX , INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-05 | Biomerieux Inc | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
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