Recall Z-1419-2023— Beckman Coulter, Inc.

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.. Reason: The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range..

Recalling firm

Beckman Coulter, Inc.

Classification

Class II

Status

Ongoing

Initiated

2023-03-15

Firm location

Chaska, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.