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QUANTA Lite® Phosphatidylserine IgG ELISA

INOVA DIAGNOSTICS, INC. · Model 704625 · UDI-DI 08426950593249

MID Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Phosphatidylserine Coated Wells: 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4. PS Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use. 5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgG ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use. 7.Phosphatidylserine IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP Phosphatidylserine IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, ready to use. 10 TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use. 11 HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use.

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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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.