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AQUIOS IMMUNO-TROL Low Cells

BECKMAN COULTER IRELAND INC. · Model B25700 · UDI-DI 15099590225865

OYEJPK Prescription
8
510(k) clearances
896
Adverse events
26
Recalls
11
Facilities

Description

AQUIOS Immuno-Trol Low Cells

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 patient results.
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 650781, Power Module AC-
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 650781, Power Module AC-
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 650781, Power Module AC-
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 650781, Power Module AC-
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 650781, Power Module AC-
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 aggregates, high background
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 processed events), which
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 processed events), which
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 processed events), which

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Data 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.