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System, Test, Anticardiolipin Immunological

FDA product code MID · Class 2 · Immunology

99
Registered devices
1
Adverse events
17
Recalls
94
510(k) clearances

Devices with this code

HemosIL AcuStar Anti-Cardiolipin IgG — INSTRUMENTATION LABORATORY COMPANYBioPlex 2200 — BIO-RAD LABORATORIES, INC.AESKULISA® Cardiolipin-GM — Aesku.Diagnostics GmbH & Co. KGCardiolipin IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungQUANTA Lite® ACA IgM III ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA Cardiolipin IgM Well — Phadia ABBioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Anti-Cardiolipin Screen ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungCorgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATIONAESKULISA® Cardiolipin-A — Aesku.Diagnostics GmbH & Co. KGQUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp) — INOVA DIAGNOSTICS, INC.QUANTA Flash® aCL IgA Reagents — INOVA DIAGNOSTICS, INC.QUANTA Lite® Phosphatidylserine IgA ELISA — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Autostat II Anti-Cardiolipin IgG — HYCOR BIOMEDICAL LLCQUANTA Lite® ACA IgM III — INOVA DIAGNOSTICS, INC.Diamedix — DIAMEDIX CORPORATIONQUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.SeraQuest — QUEST INTERNATIONAL, INC.Anti-Cardiolipin-A ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.QUANTA Lite® Phosphatidylserine IgG ELISA — INOVA DIAGNOSTICS, INC.QUANTA Lite® ACA IgA III ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.

Recent recalls

DateFirmReason
2023-02-28Bio-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.
2016-10-21Euro Diagnostica ABIncorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
2016-10-21Euro Diagnostica ABIncorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
2012-08-02Phadia US IncCustomers 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
2008-08-27Calbiotech IncThe 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 rel
2006-07-18Louisville Apl Diagnostics IncProduct mislabeled; outer container labeled with incorrect lot number.
2006-01-11Thera 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
2005-10-06Louisville Apl Diagnostics IncMislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
2005-10-06Louisville Apl Diagnostics IncMislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
2005-10-06Louisville Apl Diagnostics IncMislabeling: 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.