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Anti-Cardiolipin IgG/IgM ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3587 · UDI-DI 04048474035872
MID
Prescription
10
510(k) clearances
1
Adverse events
17
Recalls
24
Facilities
Description
Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma.
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 | 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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Get your free API keyRead the docsData 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.