Home › Device types › JSM
Culture Media, Non-Propagating Transport
FDA product code JSM · Class 1 · Microbiology
348
Registered devices
581
Adverse events
18
Recalls
111
510(k) clearances
Devices with this code
iClean — Huachenyang (Shenzhen) Technology Co., LtdStarswab II Bacteriology Culture Collection and Transport System — Pretium Canada Packaging ULCBartels — CLARK LABORATORIES, INC.C&S Medium — MEDICAL CHEMICAL CORPORATIONV-Monovette® Urine 4ml bo.acid — Sarstedt Aktiengesellschaft & Co.KGVTM-C19 Transit Tube — BIO-MED DIAGNOSTICS, INC.iClean — Huachenyang (Shenzhen) Technology Co., LtdFisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.C&S Medium — MEDICAL CHEMICAL CORPORATIONCultura™ — Merit Medical Systems, Inc.BD Universal Viral Transport — COPAN ITALIA SPAUTM® — COPAN ITALIA SPATransystem™ — COPAN ITALIA SPACARDINAL HEALTH — Cardinal Health 200, LLCPCRopsis — ENTOPSIS, LLCBACTI-SWAB — REMEL, INC.BD Vacutainer® C&S Cup Kit — BECTON, DICKINSON AND COMPANYBIOER Viral Transport Medium — Hangzhou Bioer Technology Co., Ltd.BD BBL™ Port-A-Cul™ Tube and Swabs Sterile Pack — BECTON, DICKINSON AND COMPANYTransystem™ — COPAN ITALIA SPATransPorter® — COPAN ITALIA SPAMicroTest M5 — REMEL, INC.VACUETTE — Greiner Bio-One GmbHMicroTest M4RT — 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 | 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 |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | XXX |
| 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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