# FDA recall Z-0349-2023

> **Primus Corporation dba Trinity Biotech** · Class III · device recall initiated 2021-10-05.

## Product

A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis

## Reason for recall

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months.  The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

## Distribution

Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.

## Key facts

- **Recall number:** Z-0349-2023
- **Recalling firm:** Primus Corporation dba Trinity Biotech
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-05
- **Report date:** 2022-12-07
- **Termination date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kansas City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2023

## Citation

> AI Analytics. FDA recall Z-0349-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0349-2023. Source: US FDA. Licensed CC0.

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