QUANTA Lite® Phosphatidylserine IgA ELISA
INOVA DIAGNOSTICS, INC. · Model 704635 · UDI-DI 08426950593294
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 IgA 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 APS U/mL. Ready to use. 7. Phosphatidylserine IgA 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 IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, 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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