# FDA recall Z-1303-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-02-08.

## Product

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

## Reason for recall

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

## Distribution

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E,  Vietnam, and Zimbabwe.

## Key facts

- **Recall number:** Z-1303-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-08
- **Report date:** 2024-03-27

- **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-1303-2024

## Citation

> AI Analytics. FDA recall Z-1303-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1303-2024. Source: US FDA. Licensed CC0.

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