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AccuDiag ™

Diagnostic Automation, Inc. · Model DACD-2555-2 · UDI-DI 00894175000213

510(k) clearances

Adverse events

Recalls

Facilities

Description

AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Recalls

Date	Firm	Reason
2008-08-27	Calbiotech Inc	The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to
2008-08-19	Zeus Scientific Inc	The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.

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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.