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QUANTA Lite® CCP3.1 IgG/IgA ELISA

INOVA DIAGNOSTICS, INC. · Model 704550 · UDI-DI 08426950456124

NHX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A 5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B 6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C 7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D 8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate 11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2023-02-21	Bio-Rad Laboratories, Inc.	Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot v
2023-02-21	Bio-Rad Laboratories, Inc.	Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot v
2019-08-14	Siemens Healthcare Diagnostics, Inc	Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in
2019-07-16	Roche Diagnostics Operations, Inc.	Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma sa
2019-07-16	Roche Diagnostics Operations, Inc.	Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma sa
2017-01-30	Phadia US Inc	Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems wi
2016-02-14	Euro Diagnostica AB	Decreasing performance overtime.
2005-11-11	Axis-Shield Diagnostics, Ltd.	The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather tha

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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.