LumiraDx recalls coronavirus antigen test systems that gave false positives due to failed QC testing. Stop using these products immediately to avoid inaccurate results.
Two lots of test strips failed QC testing using blank buffer due to false positives.
LumiraDx is recalling coronavirus antigen test systems that produced false positives. This means the tests might incorrectly show a positive result when there's no infection, leading to unnecessary anxiety and potential missteps in testing.
The test strips failed quality control testing with blank buffer, causing false positives. This means the tests might show a positive result even when no virus is present, leading to incorrect conclusions about infection status.
Healthcare providers who use these tests for COVID-19 screening are affected. Those who have used the recalled test systems for diagnosis are at risk of inaccurate results.
The recalled products are LumiraDx coronavirus antigen test systems with catalog number L001000330001. They were intended for use by healthcare providers testing nasal swabs from suspected COVID-19 patients.
Immediately stop using the recalled test systems to avoid false positive results.
The test strips failed quality control testing with blank buffer, causing false positives.
The catalog number is L001000330001.
The tests can produce false positives, which might lead to incorrect conclusions about infection status.
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1312-2021 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-1312-2021 from LumiraDx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
