Home › Device types › JXB
Kit, Identification, Yeast
FDA product code JXB · Class 1 · Microbiology
11
Registered devices
169
Adverse events
6
Recalls
16
510(k) clearances
Devices with this code
ID 32 C — BIOMERIEUX SABACTICARD — REMEL, INC.API® 20 C AUX — BIOMERIEUX SABD Phoenix™ YEAST ID — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) — REMEL, INC.VITEK® 2 YST — BIOMERIEUX , INC.MicroScan — Beckman Coulter, Inc.MicroScan — Beckman Coulter, Inc.Remel — REMEL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2021-12-20 | Biomerieux Inc | Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
| 2013-04-04 | Remel Inc | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. |
| 2009-10-28 | Remel, Inc | There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID |
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