medical Class II Updated 2024-11-06

Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Ins

Recalled Product

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 the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
View official government recall

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