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Access AFP

Beckman Coulter, Inc. · Model C28649 · UDI-DI 15099590744403

LOK Prescription

510(k) clearances

159

Adverse events

Recalls

Facilities

Description

The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.

Recalls

Date	Firm	Reason
2003-06-12	Abbott Laboratories HPD/ADD	AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%

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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.