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AESKULISA® SS-B

Aesku.Diagnostics GmbH & Co. KG · Model 3110 · UDI-DI 04250289500524

510(k) clearances

Adverse events

Recalls

Facilities

Description

AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE).

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.