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ASSY,Reag.Disp.Card,PrepKit 3,BenchMark
Ventana Medical Systems, Inc. · Model 05251346001 · UDI-DI 07613336125366
JRC
Prescription
6
510(k) clearances
4
Adverse events
3
Recalls
91
Facilities
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.