Beckman Coulter Inc. recalls Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use…

Recall date

April 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2242-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusett, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada,…

Why it was recalled

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.