Liquichek 395XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847661003458), received between Mar 10, 2025 and Mar 10, 2025 — classified as 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6), USA REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE AT (B)(6) CENTER IN (B)(6). ON (B)(6) 2025, A MEDICAL TECHNOLOGIST SPLASHED LIQUID IN THE EYES WHEN THROWING RACKS OF QC MATERIALS IN THE TRASH BIN. IT WAS REPORTED THAT ROCHE REAGENTS WERE ALSO INCLUDED ON THE RACK. THE RACK HIT THE TRASH AND LIQUID SPLASHED BACK IN THEIR EYES. THE MEDICAL TECHNOLOGIST IMMEDIATELY WENT TO THE EYEWASH STATION FOR 10 MINUTES AND THEN TO THE EMERGENCY DEPARTMENT TO CHECK THE EYES. THE EMERGENCY DEPARTMENT DETERMINED THAT THERE WAS NO HARM TO THE MEDICAL TECHNOLOGIST AND PRESCRIBED ANTIBIOTICS FOR PRECAUTIONS. NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE FOLLOWING QC PRODUCTS WERE REPORTED FOR THIS EVENT: LIQUICHEK ETHANOL/AMMONIA CONTROL, LOT: 54430, LIQUICHEK IMMUNOLOGY CONTROL, LOT: 85740, LIQUICHEK URINE CHEMISTRY CONTROL, LOT: 97450, LIQUICHEK CARDIAC TROPONINS CONTROL, LOT: 89091, LIQUICHEK CARDIAC TROPONINS CONTROL, LOT: 89092, LIQUICHEK CARDIAC TROPONINS CONTROL, LOT: 89093, LIQUID UNASSAYED MULTIQUAL, LOT: 56720, LIQUICHEK SPINAL FLUID CONTROL, LOT: 56540, LYPHOCHEK IMMUNOASSAY PLUS CONTROL, LOT: 40440. NO SAFETY GLASSES WERE WORN

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21565456 ↗