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MEDTOXScan®
MEDTOX DIAGNOSTICS, INC. · Model 833077 · UDI-DI 00690286000094
JRC
Prescription
3
510(k) clearances
4
Adverse events
3
Recalls
91
Facilities
Description
A micro pipette designed to dispense an accurate volume of sample for the PROFILE®-V MEDTOXScan® Test Devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-14 | Copan Diagnostics Inc | Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance |
| 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 |
| 2021-12-10 | Ortho-Clinical Diagnostics, Inc. | The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results |
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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.