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Access Intrinsic Factor Ab
Beckman Coulter, Inc. · Model 387992 · UDI-DI 15099590229146
LIG
Prescription
8
510(k) clearances
2
Adverse events
3
Recalls
5
Facilities
Description
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
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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Get your free API keyRead the docsData 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.