Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors
Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (insufficient reagents) that may lead to inaccurate test results, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kits (P/N A13422) because the kits were filled incorrectly. The affected units contain an insufficient quantity of reagents in one or more of the pack wells.
The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay used for the quantitative determination of free triiodothyronine levels in human serum and plasma. The recall involves 16,648 units total, with 1,874 units distributed in the United States. The products were distributed worldwide, including to Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand, and Viet Nam.
The affected lot number is 431433. Users should stop using the affected reagent kits and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 431433
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighBeckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts
FDA (Devices) · 2016-07-06
- HighBeckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results
FDA (Devices) · 2023-04-26
- ModerateBeckman Coulter Free T3 Immunoassay Recalled for Biotin Interference
FDA (Devices) · 2020-06-10
- LowBeckman Coulter Access Total T3 Reagent Recalled for Negative Bias
FDA (Devices) · 2012-08-29
- HighBeckman Coulter Access System-Free T4 Assay Recalled for Biotin Interference
FDA (Devices) · 2017-07-05
- ModerateBeckman Coulter Access Total T3 Assay Recalled for Biotin Interference
FDA (Devices) · 2020-06-10