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Sigma Transwab
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED · Model Amies · UDI-DI 05060259076046
10
510(k) clearances
215
Adverse events
8
Recalls
25
Facilities
Description
Sigma transwab, sigma swab ENT, 1ml liquid amies
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-02 | Copan Italia | Swabs for specimen collection may be prone to breakage during product usage. |
| 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 |
| 2022-01-27 | Hologic, Inc | Failed stability specifications for reagent kits that may result in false negative test results. |
| 2018-08-30 | Becton Dickinson & Company | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good |
| 2018-08-30 | Becton Dickinson & Company | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good |
| 2018-08-30 | Becton Dickinson & Company | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good |
| 2018-08-30 | Becton Dickinson & Company | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good |
| 2009-10-12 | Becton Dickinson & Company | A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was |
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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.