CLASS II Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
Coronavirus antigen detection test system recalled by LumiraDx
LumiraDx is recalling Coronavirus antigen detection test system, distributed nationwide in the US. The recall was initiated on 3 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1312-2021
- FDA event ID
- 87366
- Recalling firm
- LumiraDx, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2021
- FDA classified
- 26 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Feb 2021 | Recall initiated by company | |
| 26 Mar 2021 | Classified by FDA | +51 days |
| 7 Apr 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots of test strips failed QC testing using blank buffer due to false positives.
Product as listed by the FDA
Coronavirus antigen detection test system - Product Usage: intended 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.
Where it was distributed
US nationwide distribution.
Questions about this recall
Is Coronavirus antigen detection test system recalled?
Yes. LumiraDx recalled Coronavirus antigen detection test system on 3 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-1312-2021.
Why was it recalled?
Two lots of test strips failed QC testing using blank buffer due to false positives.
Which lots are affected?
catalog #: L001000330001
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LumiraDx
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SteriPack Sterile Polyester Spun Swabs/Pack)- Intended recalled | LumiraDx | Sterility | Nationwide |
| Device | CLASS III | Sars-CoV-2 Antigen (Ag) Liquid Quality Control Kit recalled by LumiraDx | LumiraDx | Other | Nationwide |
| Device | CLASS II | Sars-CoV-2 Antibody (Ab) Test Strip recalled by LumiraDx | LumiraDx | Other | 13 states |
| Device | CLASS II | Sars-CoV-2 Antibody (Ab) Liquid Quality Control recalled by LumiraDx | LumiraDx | Other | 13 states |
| Device | CLASS II | Sars-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN) recalled by LumiraDx | LumiraDx | Other | 4 states |
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