Z-0135-2023 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2022
- Initiation Date
- September 23, 2022
- Termination Date
- December 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 kits
Product Description
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023