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Gongdong
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. · Model G1026V3 · UDI-DI 06947462492476
10
510(k) clearances
581
Adverse events (1 deaths)
18
Recalls
71
Facilities
Description
INDIVIDUALLY PACKAGED,10mL Virus Collection and Preservation System(VTM),G1029FN80 Swab,3mL VTM medium
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 contamination causing fal |
| 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 lots received between 0 |
| 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 lots received between 0 |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.