Beckman Coulter Access Total T3 Reagent Recalled for Negative Bias
Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which is defined as unlikely to cause adverse health consequences. The issue is a technical bias in test results rather than a direct physical hazard like infection or injury.
Plain-English summary
Beckman Coulter Inc. is recalling the Access Total T3 Reagent, Product Number 33830. This medical device is used to measure triiodothyronine (T3) levels in human serum and plasma to assess thyroid function and diagnose thyroid disorders. The recall covers 117,385 units total, including 33,918 units in the United States, with distribution in the US, Canada, and internationally.
The recall was initiated because Beckman Coulter identified a negative bias in test results. This bias occurs when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0. The issue affects all lots of the product.
Healthcare providers and laboratories using this reagent should stop using the product and contact Beckman Coulter for further instructions. Patients who have had thyroid function tests using this specific reagent and diluent combination should consult their healthcare provider to discuss their results.
The recalled product
- Product
- Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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