---
title: "Total Thyroxine (T4) ELISA; REF EIA-1781 — FDA record Z-0310-2022 | Is It on Recall"
description: "Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a"
url: https://isitonrecall.com/recall/fda-device-z-0310-2022-total-thyroxine-t4-elisa-ref-eia-1781/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Total Thyroxine (T4) ELISA; REF EIA-1781 — FDA record Z-0310-2022

Reported ongoing

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 18, 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**: Total Thyroxine (T4) ELISA; REF EIA-1781
- **Reason**: Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
- **Classification**: Class II
- **Recalling firm**: DRG International, Inc.
- **Quantity**: 314 total (270 US)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0310-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0310-2022%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 | lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021 |

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

## Distribution

Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Colorado](https://isitonrecall.com/state/colorado/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [New York](https://isitonrecall.com/state/new-york/)

## Dates in the source

- **Report date**: Dec 8, 2021
- **Recall initiation date**: Oct 18, 2021
- **Center classification date**: Nov 29, 2021

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-0310-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [DRG International, Inc. records](https://isitonrecall.com/brand/drg-international-inc/)