Beckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results
Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic test where 15-20% of samples produce falsely elevated results that do not correlate with other thyroid markers, creating risk of misdiagnosis and inappropriate treatment. No illnesses or injuries are reported; the hazard is theoretical.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Free T3 (Triiodothyronine, Free) reagent test kits, Catalog #A13422, Lot #233968 (expiration 2023-06-30), distributed worldwide including the United States, Puerto Rico, and 19 other countries. The affected reagent packs in this lot produce elevated test results (approximately 30% or greater) in approximately 15-20% of patient samples tested.
The elevated results from this lot do not align with results from other thyroid function tests or Free T3 results obtained on other laboratory platforms. These inconsistent results risk not being detected through standard quality control procedures. When clinical staff review these results alongside other thyroid function tests, they may notice inconsistencies that prompt additional testing.
False positive (elevated) results create a risk of serious misdiagnosis and inappropriate treatment. Patients with normal thyroid function may be misinterpreted as having overactive thyroid disease and could receive anti-thyroid medications unnecessarily. Conversely, patients with underactive thyroid disease might appear to have normal thyroid function on this test and could be denied necessary treatment.
The recalled product
- Product
- Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 31,076
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 (3)
- Lot #233968
- exp. 2023-06-30
- UDI (01)15099590201661(17)230630(11)220630(10)233968.
Distribution
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