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AESKULISA® ANA-HEp-2

Aesku.Diagnostics GmbH & Co. KG · Model 7115US · UDI-DI 04250289503020

510(k) clearances

Adverse events

Recalls

Facilities

Description

AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, PM-Scl, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren`s syndrome, polymyositis and dermatomyositis.

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.