FDA Device Intelligence
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System, Transport, Aerobic

FDA product code JTW · Class 1 · Microbiology

33
Registered devices
200
Adverse events
8
Recalls
43
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-05-02Copan ItaliaSwabs for specimen collection may be prone to breakage during product usage.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2022-01-27Hologic, IncFailed stability specifications for reagent kits that may result in false negative test results.
2018-08-30Becton Dickinson & CompanyBD 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 recomm
2018-08-30Becton Dickinson & CompanyBD 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 recomm
2018-08-30Becton Dickinson & CompanyBD 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 recomm
2018-08-30Becton Dickinson & CompanyBD 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 recomm
2009-10-12Becton Dickinson & CompanyA small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.