LumiraDx SARS-CoV-2 Quality Control Kit: Incorrect Lot Numbers
LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (batch 2002204017) with incorrect vial lot numbers. The kits contain Flu A/B lot numbers instead of SARS-CoV-2 Ag numbers, causing error messages and preventing device use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with incorrect lot number assignment that prevents device use. No reported illnesses, injuries, or deaths. The error message prevents misuse rather than causing direct patient harm.
Plain-English summary
LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (catalog #L016080109002, batch 2002204017) distributed nationwide. The positive and negative control vials in the affected batch have been assigned incorrect lot numbers—specifically, lot numbers designated for SARS-CoV-2 & Flu A/B products instead of the SARS-CoV-2 Ag lot numbers that should have been used.
The LumiraDx SARS-CoV-2 Quality Controls are designed to verify that the LumiraDx Instrument is operating within specification during COVID-19 testing. Due to the incorrect lot number assignment, users who attempt to use these kits will receive an error message, preventing them from validating their device functionality.
The recalled kits have an expiration date of March 1, 2023. If you have received batch 2002204017, do not use the affected quality control kits. Contact LumiraDx for guidance on replacement or disposal of the product.
The recalled product
- 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.…
- Manufacturer
- LumiraDx
- Category
- Medical Device
- Hazard
- Affected units
- 83
Distribution
Distributed nationwide across the United States.
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