FDA Medical Device Recalls (openFDA)
LumiraDx: 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
- Recall number
- Z-0135-2023
- Recalling firm
- LumiraDx
- 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
- Status
- Terminated
- Initiated
- 2022-09-23
- Posted
- 2022-10-26
- Terminated
- 2024-12-13
- Reason
- 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
- Root cause
- Error in labeling
- Action
- LumiraDx issued Urgent Product Recall Notice and were provided with an attestation form to document product destruction at their facility via email on 23 September 2022. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lots of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls. " Remove from your stock any remaining affected kits of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls as listed in Table 1. " Ensure any of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls are removed from your inventory are destroyed (not just thrown away), indicate the number of Liquid Quality Control kits that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls in your inventory. " Report any issues or adverse events with using the LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product over the course of the next few days. If you have any questions, contact LumiraDx Customer Services at customerservices.US@lumiradx.com or 1-888-586-4721.
- Quantity
- 83 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3012642695
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28