Liquichek 360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847661001119), received between Mar 9, 2020 and Mar 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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 9, 2020Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2020, A LABORATORY INFORMATION MANAGER FROM (B)(6) MEDICAL CENTER- (B)(6) CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT THAT OCCURRED WITH A TECHNICIAN AT THEIR FACILITY. IN THE FACILITY CHEMISTRY LAB, THE EMPLOYEE REMOVED QC RACK FROM INSTRUMENT AND EMPTIED A RACK OF QC VIALS INTO SINK. WHILE DUMPING, THE MIXTURE OF QC SPLASHED INTO THE TECHNICIAN'S EYES. THE TECHNICIAN WAS NOT WEARING SAFETY GLASSES, WHICH IS A LABORATORY REQUIREMENT FOR PPE IN THIS FACILITY. THE FOLLOWING QC PRODUCTS WERE ON THE QC RACK AND PLASHED IN THE TECHNICIAN'S EYES: LIQUICHEK IMMUNOASSAY PLUS CONTROL: TRILEVEL: LOT 41000. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT: LEVEL 2: LOT 23692, LEVEL 3: LOT 23693, LEVEL 1B: LOT 23695. LIQUID ASSAYED MULTIQUAL: LEVEL 1: LOT 45791, LEVEL 3: LOT 45793. THE EMPLOYEE WASHED EYES IMMEDIATELY IN THE EMERGENCY EYE WASH STATION. THE INCIDENT WAS REPORTED TO FACILITIES HEALTH AND THE EMPLOYEE WAS SENT TO THE EMPLOYEE HEALTH CENTER FOR EVALUATION. NO DETAILS OF THE VISIT TO EMPLOYEE HEALTH CENTER WAS PROVIDED. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE EMPLOYEE AND FACILITY WAS PROVIDED WITH PACKAGE INSERT, SDS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806089 ↗