---
title: "Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 — FDA record Z-0659-2022 | Is It on Recall"
description: "The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers"
url: https://isitonrecall.com/recall/fda-device-z-0659-2022-celltrion-diatrust-covid-19-ag-rapid-test-reference-no-ct-p60-d-2-02/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 — FDA record Z-0659-2022

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 Dec 28, 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**: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- **Reason**: The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
- **Classification**: Class I
- **Recalling firm**: CELLTRION USA INC
- **Quantity**: 243 kits (6,075 tests)
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0659-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0659-2022%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 COVGCCM0008 |

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

## Distribution

US distribution to CA, FL, NJ, NY, PA, SC.

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

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)

## Dates in the source

- **Report date**: Mar 9, 2022
- **Recall initiation date**: Dec 28, 2021
- **Center classification date**: Mar 2, 2022
- **Termination date**: Jun 10, 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-0659-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [CELLTRION USA INC records](https://isitonrecall.com/brand/celltrion-usa-inc/)