Beckman Coulter recalls Access Free T3 reagent packs (Lot #233968) that may cause false positive thyroid test results, leading to incorrect treatment decisions. Affected units may require additional testing to avoid misdiagnosis.
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.
Beckman Coulter is recalling Access Free T3 reagent packs that can produce false positive results in some thyroid tests. This may cause patients to be misdiagnosed as having hyperthyroidism when they are not, or not receiving proper treatment for hypothyroidism.
The reagent lot produces false positive results in 15-20% of patient samples, causing thyroid tests to show elevated levels when they are not. This can lead to unnecessary anti-thyroid medication for euthyroid patients or inadequate treatment for hypothyroid patients.
Patients using thyroid function tests with the affected reagent packs may be at risk of misdiagnosis. Healthcare providers ordering the reagent packs are most affected.
Check for the lot number 233968 on the reagent box. The expiration date is June 30, 2023. The product is sold under catalog number A13422.
Look for lot number 233968 on the reagent box to confirm if it is affected.
No, the recall does not indicate a risk of serious injury. The hazard is a potential for misdiagnosis requiring additional testing.
Check the lot number on the reagent box; affected units have lot number 233968 with expiration date June 30, 2023.
The recall does not specify a remedy, so contact Beckman Coulter for guidance on next steps.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1419-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1419-2023 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
