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QUANTA Flash® RNP Reagents

INOVA DIAGNOSTICS, INC. · Model 701118 · UDI-DI 08426950595151

LKO Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Description

1. 1 QUANTA Flash RNP Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet

Recalls

DateFirmReason
2016-10-21Euro Diagnostica ABIncorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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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.