LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The FDA classified this as a Class II recall. The issue is that modifications to the test were implemented outside the scope of FDA-approved authorization, which is a regulatory compliance concern rather than a reported safety incident with documented illnesses or injuries.
Plain-English summary
LumiraDx is recalling SARS-CoV-2 Antibody (Ab) Liquid Quality Control products due to a modification that was made to the test outside the scope of the FDA-approved Emergency Use Authorization (EUA). The product is LumiraDx SARS-CoV-2 Antibody Liquid Quality Control.
The recall impacts 99 units of Lot No. 2002201428 (with an expiration date of September 1, 2022) that were distributed within the United States to Arkansas, California, Florida, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Oklahoma, Tennessee, Texas, and Wisconsin.
Because a modification was implemented without FDA authorization, the device's performance and reliability may not have been adequately evaluated. Facilities currently using this product should discontinue use immediately and contact LumiraDx or the FDA for guidance on proper return or disposal.
The recalled product
- Product
- LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
- Manufacturer
- LumiraDx
- Affected units
- 99
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
Distribution
Part of a larger recall action
This product is one of 2 recalled by LumiraDx under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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