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NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach

INOVA DIAGNOSTICS, INC. · Model 708155 · UDI-DI 08426950596387

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510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 20x 4-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips

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.