MAUDE Adverse Event Report: LUCIRA HEALTH, INC. LUCIRA RAPID PCR COVID TESTS; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

[lucira] use for covid-19 under emergency use authorization (eua): lucira tests do not actually process the specimen.They give random results, but do not go through any molecular type process to detect covid.They are a fraud.Fda safety report id# (b)(4).

• Brand Name: LUCIRA RAPID PCR COVID TESTS
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): LUCIRA HEALTH, INC.; 1412 62nd street; emeryville CA 94608
• MDR Report Key: 14755148
• MDR Text Key: 294574442
• Report Number: MW5110384
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other