Summary
The FDA issued a Class II for LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control by LumiraDx. Reason: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA..
Details
Source
Device Recall
External ID
Z-1451-2022
Action Date
2022-07-27
Status
Terminated
Category
device
Product Description
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Lot/Code Info: No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
Quantity Affected: 99 units
Reason for Recall
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Distribution
Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LumiraDx has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LumiraDx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LumiraDx have FDA actions?
LumiraDx has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1451-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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