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.
What this means for you
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.
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