# FDA recall Z-1419-2023

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-03-15.

## Product

Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

## Reason for recall

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 euthyr

## Distribution

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of  Bahrain, Brazil, Canada, China, Costa Rica, El Salvador, Georgia,  Hong Kong, Malaysia, Mexico, Myanmar, New Zealand, Peru, Philippines, Qatar, Singapore, Taiwan, Thailand, Uruguay, and Viet Nam.

## Key facts

- **Recall number:** Z-1419-2023
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-15
- **Report date:** 2023-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1419-2023

## Citation

> AI Analytics. FDA recall Z-1419-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1419-2023. Source: US FDA. Licensed CC0.

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