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Gamma EGA Kit

IMMUCOR, INC. · Model 0007865 · UDI-DI 10888234000877

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

Description

Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.

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.