---
title: "BIOPHEN UFH Control Plasma — FDA record Z-1743-2022 | Is It on Recall"
description: "Incorrect product labeling was included in the package."
url: https://isitonrecall.com/recall/fda-device-z-1743-2022-biophen-ufh-control-plasma/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# BIOPHEN UFH Control Plasma — FDA record Z-1743-2022

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 Jun 28, 2022. 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**: BIOPHEN UFH Control Plasma
- **Reason**: Incorrect product labeling was included in the package.
- **Classification**: Class III
- **Recalling firm**: Aniara Diagnostica LLC
- **Quantity**: 13 units (1 unit is 1 box)
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1743-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1743-2022%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 | UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035 |

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

## Distribution

Distribution in US - IL and MI

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

- [Illinois](https://isitonrecall.com/state/illinois/)
- [Michigan](https://isitonrecall.com/state/michigan/)

## Dates in the source

- **Report date**: Sep 21, 2022
- **Recall initiation date**: Jun 28, 2022
- **Center classification date**: Sep 15, 2022
- **Termination date**: Apr 18, 2024

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-1743-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Aniara Diagnostica LLC records](https://isitonrecall.com/brand/aniara-diagnostica-llc/)