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ANTI-CARDIOLIPIN SCREEN

ORGENTEC Diagnostika GmbH · Model ORG515S · UDI-DI 04260157080140

MID Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

Recalls

Date	Firm	Reason
2023-02-28	Bio-Rad Laboratories, Inc.	APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
2016-10-21	Euro Diagnostica AB	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
2016-10-21	Euro Diagnostica AB	Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
2012-08-02	Phadia US Inc	Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash s
2008-08-27	Calbiotech Inc	The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,
2006-07-18	Louisville Apl Diagnostics Inc	Product mislabeled; outer container labeled with incorrect lot number.
2006-01-11	Thera Test Laboratories, Inc.	The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.
2005-10-06	Louisville Apl Diagnostics Inc	Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
2005-10-06	Louisville Apl Diagnostics Inc	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
2005-10-06	Louisville Apl Diagnostics Inc	Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

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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.