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AQUIOS

BECKMAN COULTER IRELAND INC. · Model B25698 · UDI-DI 15099590225841

JCBOYE Prescription
0
510(k) clearances
31
Adverse events
3
Recalls
44
Facilities

Description

AQUIOS Cleaning Agent

Recalls

DateFirmReason
2024-08-29Microcare MedicalContaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic deter
2013-11-08Beckman Coulter Inc.Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nuc
2013-11-08Beckman Coulter Inc.Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nuc

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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.