Simplexa™ HSV 1 & 2 Direct MOL2150Recalls & reported problems
Diasorin Molecular LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20816101025507), received between May 22, 2026 and May 22, 2026 — classified as 1 death.
The most frequently reported specific device problem is “False Negative Result” (1 report).
2 other recalls cover devices cleared under the same FDA submission (DEN130049, K150962); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 22, 2026False Negative Result
DIASORIN MOLECULAR RECEIVED A COMPLAINT BY PHONE ON (B)(6) 2026 ON THE SIMPLEXA HSV 1&2 DIRECT ASSAY MOL2150 LOT 23498N FOR A SUSPECTED FALSE NEGATIVE HSV RESULT WHILE RUNNING AN INFANT BLOOD SAMPLE. THE CUSTOMER STATED THE FIRST TEST WAS RUN ON (B)(6) 2026 AND RESULTED HSV NEGATIVE FOR BOTH HSV-1 AND HSV-2. BASED ON THE NEGATIVE HSV RESULT, THE PATIENT WAS TREATED WITH ACYCLOVIR STARTING ON (B)(6) 2026 AND DISCONTINUED THE TREATMENT ON (B)(6) 2026. A NEW BLOOD SAMPLE WAS OBTAINED AND RUN ON (B)(6) 2026 ON A DIFFERENT LOT OF MOL2150 (LOT 23863N) AND RESULTED HSV-2 POSITIVE. ACYCLOVIR TREATMENT WAS RESTARTED ON (B)(6) 2026 AT 17:47, BUT THE PATIENT IS DECEASED AS OF (B)(6) 2026 AT 20:54.
Patient problems: Unspecified Infection
MAUDE report 25257310 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under DEN130049, K150962. One submission often covers many models, so check the product and lot details in each record.
- Z-2547-2020 · May 12, 2020 · TerminatedMOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection a
- Z-1272-2016 · Feb 10, 2016 · TerminatedSimplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page