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QUANTA Lite® ENA 4 ELISA

INOVA DIAGNOSTICS, INC. · Model 708555 · UDI-DI 08426950454496

LLL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 1x ENA 4 ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 4 ELISA Low Positive 4. 1x 1.2mL prediluted ENA 4 ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2012-08-06	Diamedix Corporation	Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
2011-06-08	Diamedix Corporation	On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an e
2008-11-25	Immuno Concepts Inc	In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
2004-04-20	Diasorin Inc.	An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.

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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.