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AESKULISA® ß2-Glyco-A

Aesku.Diagnostics GmbH & Co. KG · Model 7205US · UDI-DI 04250289503075

510(k) clearances

Adverse events

Recalls

Facilities

Description

AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Recalls

Date	Firm	Reason
2004-10-26	Diasorin Inc.	Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml,

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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.