# FDA recall Z-1312-2021

> **LumiraDx** · Class II · device recall initiated 2021-02-03.

## Product

Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.

## Reason for recall

Two lots of test strips failed QC testing using blank buffer due to false positives.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-1312-2021
- **Recalling firm:** LumiraDx
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-03
- **Report date:** 2021-04-07
- **Termination date:** 2022-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2021

## Citation

> AI Analytics. FDA recall Z-1312-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1312-2021. Source: US FDA. Licensed CC0.

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