Home › Device types › JSM
Culture Media, Non-Propagating Transport
FDA product code JSM · Class 1 · Microbiology
365
Registered devices
583
Adverse events
18
Recalls
111
510(k) clearances
Devices with this code
C&S Medium — MEDICAL CHEMICAL CORPORATIONMicroTest M6 — REMEL, INC.Gongdong — ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.TransPorter® — COPAN ITALIA SPAKaiBiLi Extended ViralTrans — Hangzhou Genesis Biodetection & Biocontrol Co., LTD.Para-Pak LV-PVA / 10% Formalin / C&S — MERIDIAN BIOSCIENCE, INC.BD™ Universal Viral Transport Flock Flex Mini — BECTON, DICKINSON AND COMPANYFisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.MicroTest M4RT — REMEL, INC.Gongdong — ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.Para-Pak EcoFix / C&S / Clean — MERIDIAN BIOSCIENCE, INC.BD Universal Viral Transport — COPAN ITALIA SPABabio — Jinan Babio Biotechnology Co., Ltd.Copan Universal Transport Medium (UTM-RT) System — COPAN ITALIA SPAAtida Viral Transport Medium (Non-inactivated Type) — ACESO LABORATORIES INC.Transystem™ — COPAN ITALIA SPATransPorter® — COPAN ITALIA SPABIOER Viral Transport Medium — Hangzhou Bioer Technology Co., Ltd.MicroTest M4RT — REMEL, INC.BD™ Universal Viral Transport Flock Mini — BECTON, DICKINSON AND COMPANYCARDINAL HEALTH — Cardinal Health 200, LLCGongdong — ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.BACTI-SWAB — REMEL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-20 | Cepheid | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross conta |
| 2022-08-12 | American Contract Systems, Inc. | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | XXX |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-02 | American Contract Systems, Inc. | Affected products were assembled off-site by individuals who may not have been properly trained. |
| 2022-05-02 | American Contract Systems, Inc. | Affected products were assembled off-site by individuals who may not have been properly trained. |
| 2021-03-18 | Gentueri Inc | Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing. |
| 2021-03-11 | Krishe Inc | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| 2021-03-11 | Krishe Inc | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
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