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QUANTA Lite® Intrinsic Factor ELISA

INOVA DIAGNOSTICS, INC. · Model 708780 · UDI-DI 08426950454526

LIG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1.1x Intrinsic Factor ELISA microwell plate, (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x1.2mL prediluted Intrinsic Factor ELISA Low Positive 4.1x 1.2mL prediluted Intrinsic Factor ELISA High Positive 5.1x 50mL HRP Sample Diluent 6.1x 25mL HRP Wash Concentrate, 40x concentrate 7.1x 10mL HRP IgG Conjugate, (goat) 8.1x 10mL TMB Chromogen 9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2009-05-07	Beckman Coulter Inc.	The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an i
2006-03-08	Abbott Laboratories MPG	The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent k
2004-08-19	Abbott Laboratories HPD/ADD/GPRD	Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decrea

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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.