# FDA recall Z-0100-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-07-06.

## Product

Access Thyroglobulin Calibrators

## Reason for recall

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

## Distribution

worldwide except US, Canada, and China

## Key facts

- **Recall number:** Z-0100-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-06
- **Report date:** 2023-10-18

- **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-0100-2024

## Citation

> AI Analytics. FDA recall Z-0100-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0100-2024. Source: US FDA. Licensed CC0.

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