---
title: "Primus Corporation dba Trinity Biotech Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall"
description: "Search Primus Corporation dba Trinity Biotech recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions."
url: https://isitonrecall.com/brand/primus-corporation-dba-trinity-biotech/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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# Primus Corporation dba Trinity Biotech recall records

**0** reported ongoing

2 records in this archive. Latest source date Oct 5, 2021.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

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/).

## Records and reported status

Oct 5, 2021 FDA device enforcement

### [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](https://isitonrecall.com/recall/fda-device-z-0349-2023-a-menarini-diagnostics-hb-9210-premier-level1-level-ii-hemoglobin-a1c-controls-for-hemoglobin-a1c-as/)

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 ...

Class III Reported terminated

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

[Official source for A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0349-2023%22)

Oct 5, 2021 FDA device enforcement

### [Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis](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/)

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 ...

Class III Reported terminated

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

[Official source for Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0350-2023%22)

## Reasons in these listed records

- 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 associ...
- 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 ...

These examples come from this result page and are not a ranking of every recall reason.

## Checking Primus Corporation dba Trinity Biotech

### Is there a recall on primus corporation dba trinity biotech right now?

This archive contains 2 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

### How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier.

### Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

### What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices.

### Where can I find older records?

Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

## Keep checking

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