---
title: "LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip — FDA record Z-1450-2022 | Is It on Recall"
description: "Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA."
url: https://isitonrecall.com/recall/fda-device-z-1450-2022-lumiradx-sars-cov-2-antibody-ab-test-strip/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip — FDA record Z-1450-2022

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 24, 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**: LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- **Reason**: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
- **Classification**: Class II
- **Recalling firm**: LumiraDx
- **Quantity**: 635 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1450-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1450-2022%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 | No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022). |

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

## Distribution

Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.

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

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Jul 27, 2022
- **Recall initiation date**: Jun 24, 2022
- **Center classification date**: Jul 21, 2022
- **Termination date**: May 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-1450-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [LumiraDx records](https://isitonrecall.com/brand/lumiradx/)