---
title: "Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... — FDA record Z-0350-2023 | Is It on Recall"
description: "The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per t"
url: https://isitonrecall.com/recall/fda-device-z-0350-2023-trinity-biotech-hba1c-ghb-contorls-kit-500ul-levels-i-ii-ref-01-04-0020-part-number-05-01-0040b-a1c/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis — FDA record Z-0350-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 5, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
- **Reason**: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, 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.
- **Classification**: Class III
- **Recalling firm**: Primus Corporation dba Trinity Biotech
- **Quantity**: 182 kits
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0350-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0350-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 0539151674808, Lot 12161 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 7, 2022
- **Recall initiation date**: Oct 5, 2021
- **Center classification date**: Dec 1, 2022
- **Termination date**: Aug 9, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0350-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Primus Corporation dba Trinity Biotech records](https://isitonrecall.com/brand/primus-corporation-dba-trinity-biotech/)