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NOVA Lite® HEp-2 External EB Kits

INOVA DIAGNOSTICS, INC. · Model 704230 · UDI-DI 08426950595267

DHN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Control 4. 1x 1mL IFA System Negative Control 5. 1x 7mL FITC IgG (H&L) HEp Conjugate 6. 1x 3mL PVA Mounting Medium 7. 2x 25mL PBS II Concentrate (40x) 8. 1x 3mL 1% Evans Blue 9. 1x 10 Coverslips

Recalls

Date	Firm	Reason
2011-09-26	Inova Diagnostics Incorporated	The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with
2010-06-30	Bio-Rad Laboratories	KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
2008-12-04	Immuno Concepts Inc	Samples can occasionally run out of the wells and cross contaminate adjacent wells.
2008-07-29	Bio-Rad Laboratories	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
2004-09-24	Diasorin Inc.	A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (includi
2004-06-30	Diasorin Inc.	The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrect
2003-07-21	Perkinelmer Life Sciences, Inc.	Product's outer carton label was labeled with an extended expiration date

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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.