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ELUclear

HEMO BIOSCIENCE INC · Model H360 · UDI-DI 00858352006023

KSG
10
510(k) clearances
11
Adverse events
1
Recalls
14
Facilities

Description

ELUclear elution kit is used to elute antibodies from intact red blood cells.

Recalls

DateFirmReason
2019-10-14Ortho Clinical Diagnostics IncPotential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7

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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.