Home › Device types › JSI
Culture Media, Selective And Differential
FDA product code JSI · Class 1 · Microbiology
448
Registered devices
298
Adverse events
24
Recalls
285
510(k) clearances
Devices with this code
N/A — HARDY DIAGNOSTICSREMEL — REMEL, INC.HardyCHROM — HARDY DIAGNOSTICSPRAS Cycloserine Cefoxitin Mannitol Broth w/ Taurocholate & Lysozyme (CCMB-TAL) — ANAEROBE SYSTEMSN/A — HARDY DIAGNOSTICSREMEL — REMEL, INC.BD BBL™ Sabouraud Dextrose Agar with Chloramphenicol Slants — BECTON, DICKINSON AND COMPANYEDGE BIOLOGICALS INC — EDGE BIOLOGICALS, INC.Redipor — AnalytiChem USA, Inc.AnaeroGRO — HARDY DIAGNOSTICSN/A — HARDY DIAGNOSTICSEDGE BIOLOGICALS INC — EDGE BIOLOGICALS, INC.N/A — HARDY DIAGNOSTICSCHROMID® Salmonella Elite — BIOMERIEUX SAN/A — HARDY DIAGNOSTICSREMEL — REMEL, INC.HardyCHROM — HARDY DIAGNOSTICSREMEL — REMEL, INC.BD BBL™ Mannitol Salt Agar — BECTON, DICKINSON AND COMPANYRedipor — AnalytiChem USA, Inc.HardyCHROM — HARDY DIAGNOSTICSRedipor — AnalytiChem USA, Inc.REMEL — REMEL, INC.N/A — HARDY DIAGNOSTICS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2025-02-13 | Remel, Inc | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appea |
| 2025-02-13 | Remel, Inc | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appea |
| 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 |
| 2020-12-10 | Remel Inc | The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. |
| 2018-08-02 | Acumedia Manufacturers, Inc. | Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November |
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