Simplexa COVID-19 Direct MOL4150Recalls & reported problems
Diasorin Molecular LLC · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20816101027020), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jan 30, 2023Open, Classified
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Z-1209-2023 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024False Positive Result; False Positive Result
DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ON (B)(6) 2024, ALLEGING FALSE POSITIVE RESULTS WITH THE SIMPLEXA COVID-19 DIRECT ASSAY WITH ONLY 1 OF 2 TARGETS DETECTED (NO S-GENE, BUT ORF1AB DETECTED). UPON REPEAT ON A COMPETITOR ASSAY (BD-MAX), THE RESULTS WERE NEGATIVE. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679515 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.