Home › Device types › MID
System, Test, Anticardiolipin Immunological
FDA product code MID · Class 2 · Immunology
100
Registered devices
1
Adverse events
17
Recalls
94
510(k) clearances
Devices with this code
DIASTAT anti-Cardiolipin IgM — Svar Life Science ABBioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Lite® ACA IgM III — INOVA DIAGNOSTICS, INC.AESKULISA® Cardiolipin-GM — Aesku.Diagnostics GmbH & Co. KGAESKULISA® Cardiolipin-Check — Aesku.Diagnostics GmbH & Co. KGAutoimmune EIA — BIO-RAD LABORATORIES, INC.AESKULISA® Cardiolipin-A — Aesku.Diagnostics GmbH & Co. KGQUANTA Lite® ACA IgG III — INOVA DIAGNOSTICS, INC.QUANTA Lite® Phosphatidylserine IgG ELISA — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.ANTI-CARDIOLIPIN IgA — ORGENTEC Diagnostika GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.Anti-Cardiolipin IgA ELISA — DRG International IncAptiva® APS IgG Reagent — INOVA DIAGNOSTICS, INC.QUANTA Lite® ACA IgA III — INOVA DIAGNOSTICS, INC.EliA Cardiolipin IgG Well — Phadia ABANTI-CARDIOLIPIN SCREEN — ORGENTEC Diagnostika GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.HemosIL CL Anti-Cardiolipin IgM — INSTRUMENTATION LABORATORY COMPANYQUANTA Lite® Phosphatidylserine IgM ELISA — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Cardiolipin IgA ELISA — DRG International IncEliA Cardiolipin IgM Well — Phadia AB
Recent 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 |
| 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 rel |
| 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 |
| 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 | 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. |
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