—#199210

Product

Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

FDA product code: CDP — Radioimmunoassay, Total Triiodothyronine
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

The recalling firm issued letters dated 3/8/2023 via mail and email. The letter described the issue, impact, and actions to be taken. The actions included discontinuing use of the affected lot and discard all remaining reagent packs from this lot. The letter is to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The consignee is to contact their local Beckman Coulter representative for replacement product requests. If the product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. A response was requested within 10 days via email or completion and return of the enclosed response form. The response form is to indicate the letter has been read and understood and all relevant personnel have been informed of its contents. The consignee is also to indicate whether or not they had the affected product.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Brazil, Canada, China, Costa Rica, El Salvador, Georgia, Hong Kong, Malaysia, Mexico, Myanmar, New Zealand, Peru, Philippines, Qatar, Singapore, Taiwan, Thailand, Uruguay, and Viet Nam.

Timeline

Recall initiated: 2023-03-15
Posted by FDA: 2023-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.