Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reag...
FDA Device Recall #Z-1419-2023 — Class II — March 15, 2023
Recall Summary
| Recall Number | Z-1419-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beckman Coulter, Inc. |
| Location | Chaska, MN |
| Product Type | Devices |
| Quantity | 31,076 units |
Product Description
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
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.
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.
Lot / Code Information
Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.
Other Recalls from Beckman Coulter, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1235-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44... | Dec 23, 2025 |
| Z-1025-2026 | Class II | Beckman Coulter UniCel Dxl 600, Part numbers: ... | Nov 26, 2025 |
| Z-1026-2026 | Class II | Beckman Coulter UniCel Dxl 800, Part numbers: ... | Nov 26, 2025 |
| Z-1221-2026 | Class II | COULTER DxH Diluent, REF 628017 COULTER DxH EC... | Nov 10, 2025 |
| Z-0889-2026 | Class II | Access 2 Reaction Vessels, individual, disposab... | Nov 7, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.