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
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