FDA Device Intelligence
HomeDevice types › OYE

Flow Cytometric Reagents And Accessories.

FDA product code OYE · Class 2 · Hematology

79
Registered devices
896
Adverse events
26
Recalls
8
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-09-22Beckman Coulter Inc.Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed pati
2024-11-01Becton, Dickinson and Company, BD Bio SciencesOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 6507
2024-11-01Becton, Dickinson and Company, BD Bio SciencesOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 6507
2024-11-01Becton, Dickinson and Company, BD Bio SciencesOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 6507
2024-11-01Becton, Dickinson and Company, BD Bio SciencesOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 6507
2024-11-01Becton, Dickinson and Company, BD Bio SciencesOn October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 6507
2024-05-08Becton, Dickinson and Company, BD BiosciencesMultitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggrega
2019-08-19Becton, Dickinson and Company, BD BiosciencesFlow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total proce
2019-08-19Becton, Dickinson and Company, BD BiosciencesFlow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total proce
2019-08-19Becton, Dickinson and Company, BD BiosciencesFlow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total proce

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