LumiraDx

Complete recall history across all FDA and CPSC categories — 6 total recalls

LumiraDx appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by LumiraDx

Date Product Reason Class
Apr 25, 2023 SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c... Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be m... Class II
Sep 23, 2022 LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu... Class III
Jun 24, 2022 LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outs... Class II
Jun 24, 2022 LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outs... Class II
Feb 3, 2021 Coronavirus antigen detection test system - Product Usage: intended for the q... Two lots of test strips failed QC testing using blank buffer due to false pos... Class II
Jan 11, 2021 LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Sever... Observations of potential false positive results in the specified lots. Use o... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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