Class 2 Device Recall Beckman Coulter Access Free T3

• Date Initiated by Firm: March 15, 2023
• Date Posted: April 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1419-2023
• Recall Event ID: 91916
• Product Classification: Radioimmunoassay, total triiodothyronine - Product Code CDP
• Product: Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
• Code Information: Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Adam Viitala; 714-993-5321
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 31,076 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.