Reported Nov 2, 2022 · Terminated
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2…
LumiraDx
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LumiraDx · 221 Crescent St · Waltham, MA · 02453-3475
Is this the product you have?
- 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
- Lot codes and dates
- LQC Kit2002204017
- Positive Control Vial1000 1710 0014 0141
- Negative Control Vial1000 1720 0014 0142 Exp
- Date01-Mar-2023
- Amount recalled
- 83 kits
Where it was sold
- Nationwide
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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