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Radioassay, Intrinsic Factor Blocking Antibody

FDA product code LIG · Class 2 · Clinical Chemistry

4
Registered devices
2
Adverse events
3
Recalls
8
510(k) clearances

Devices with this code

Access Intrinsic Factor Ab — Beckman Coulter, Inc.IMMULITE® 2000 Systems VB Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDQUANTA Lite® Intrinsic Factor ELISA — INOVA DIAGNOSTICS, INC.IMMULITE® 2000 Systems VB Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Recent recalls

DateFirmReason
2009-05-07Beckman 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
2006-03-08Abbott Laboratories MPGThe 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
2004-08-19Abbott Laboratories HPD/ADD/GPRDChanges 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 lo

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.