# FDA recall Z-1818-2024

> **QUIDELORTHO** · Class II · device recall initiated 2024-04-09.

## Product

VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin).  Product Code: 131 5589

## Reason for recall

T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany,  India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore , Spain, Sweden,  The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-1818-2024
- **Recalling firm:** QUIDELORTHO
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-09
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2024

## Citation

> AI Analytics. FDA recall Z-1818-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1818-2024. Source: US FDA. Licensed CC0.

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