Home › Device types › LTT
Panels, Test, Susceptibility, Antimicrobial
FDA product code LTT · Class 2 · Microbiology
99
Registered devices
98
Adverse events
13
Recalls
50
510(k) clearances
Devices with this code
Sensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDSelux 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.Sensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDMicroScan — 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.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-08 | Beckman Coulter, Inc. | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. |
| 2025-07-24 | Beckman Coulter, Inc. | Due to the likely presence of contamination in well(s). |
| 2025-06-25 | Beckman Coulter, Inc. | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics |
| 2018-05-04 | Beckman Coulter Inc. | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported. |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Coll |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Coll |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Coll |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Coll |
| 2015-12-01 | Beckman Coulter Inc. | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Coll |
| 2015-09-10 | Beckman Coulter Inc. | Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential |
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