# FDA recall Z-0135-2023

> **LumiraDx** · Class III · device recall initiated 2022-09-23.

## Product

LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit  Catalog #: L016080109002 (EUA)    The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality  control testing performed on the LumiraDx Instrument when used with  the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users  with assurance that the device is performing within specification

## Reason for recall

Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0135-2023
- **Recalling firm:** LumiraDx
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-23
- **Report date:** 2022-11-02
- **Termination date:** 2024-12-13

- **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-0135-2023

## Citation

> AI Analytics. FDA recall Z-0135-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0135-2023. Source: US FDA. Licensed CC0.

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