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Direct Amplification Disc Kit MOL1455Recalls & reported problems

Diasorin Molecular LLC · Class 2

2 open recalls name 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
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30816101025092), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

2 FDA recall records name this device's identifier, 2 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.

Recalls naming this device

  1. Jun 14, 2023Open, Classified

    There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

    Z-2153-2023 · Root cause: Under Investigation by firm · FDA record ↗

  2. Nov 19, 2021Open, Classified

    A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

    Z-0457-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Leak/Splash1

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.

  • MalfunctionJun 9, 2023Leak/Splash; Leak/Splash

    A CUSTOMER COMPLAINT COMPLAINT WO# (B)(4) WAS RECEIVED ON 5/9/2023 ALLEGING A LEAKAGE ON THE DIRECT AMPLIFICATION DISC MOL1455 LOT P17731N WHILE RUNNING THE SIMPLEXA CONGENITAL CMV DIRECT KIT MOL2255. AFTER THE 1ST RUN OF A FULL 8-WELL DISC, FLUID WAS OBSERVED ON THE OUTSIDE OF WEDGE 4. ON THE NEXT RUN OF ANOTHER FULL 8-WELL DISC, FLUID WAS OBSERVED OUTSIDE OF WEDGES 4 AND 8. EACH SAMPLE THAT LEAKED WAS INVALIDATED DUE TO THE INTERNAL CONTROL NOT BEING DETECTED. NO PATIENT TESTING WAS PERFORMED AS THE LEAK OCCURRED DURING CUSTOMER TRAINING USING KNOWN POSTIVE SAMPLES, KNOWN NEGATIVE SAMPLES, AND CONTROL SAMPLES (NC, PC). NO PATIENT HARM OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17101714 ↗

Other Real Time Nucleic Acid Amplification System devices

All Real Time Nucleic Acid Amplification System devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.