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Para-Pak C&S
MERIDIAN BIOSCIENCE, INC. · Model 900612 · UDI-DI 00840733102011
JSM
Prescription
1
510(k) clearances
581
Adverse events (1 deaths)
18
Recalls
71
Facilities
Description
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
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.