Beckman Coulter, Inc.: Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for

Hazard

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Details from the source

Reason for recall: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. Distribution: Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico. Quantity: 465,481 kits Lot/code info: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

UPC codes

15099590202910

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.