Reported Apr 7, 2021 · Terminated
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid…
LumiraDx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Coronavirus antigen
- detection test system - Product Usageintended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset
- Lot codes and dates
- catalog #: L001000330001
- Amount recalled
- 2186 devices
Where it was sold
- Nationwide
Why it was recalled
Two lots of test strips failed QC testing using blank buffer due to false positives.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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