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Gamma N-HANCE

IMMUCOR, INC. · Model 0705410 · UDI-DI 10888234001812

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

Description

Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.

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.