Home › Pretium Canada Packaging ULC › Starswab II Bacteriology Culture Collection and Transport System
Starswab II Bacteriology Culture Collection and Transport System
Pretium Canada Packaging ULC · Model SP132-FL · UDI-DI 00840165400280
10
510(k) clearances
581
Adverse events (1 deaths)
18
Recalls
71
Facilities
Description
Starswab II Bacteriology Culture Collection and Transport System with Liquid Stuart medium and standard plastic shaft nylon flocked swab.
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 | 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 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 |
| 2022-05-02 | 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.