# FDA recall Z-1132-2021

> **LumiraDx** · Class II · device recall initiated 2021-01-11.

## Product

LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN).  LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048.    Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

## Reason for recall

Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.

## Distribution

Worldwide distribution.  US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.

## Key facts

- **Recall number:** Z-1132-2021
- **Recalling firm:** LumiraDx
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-11
- **Report date:** 2021-02-24
- **Termination date:** 2021-12-03

- **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-1132-2021

## Citation

> AI Analytics. FDA recall Z-1132-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1132-2021. Source: US FDA. Licensed CC0.

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