Skip to content

Liquichek 27113Recalls & reported problems

Bio-Rad Laboratories, Inc. · Liquichek Immunoassay Premium Control Level 3 (A processed human serum assayed immunoassay Control.) · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847661005186), received between Sep 18, 2019 and Sep 18, 2019 — 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

Device problems

  • Human-Device Interface Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

    ON 08/21/2019, A NURSE FROM (B)(6) HOSPITAL CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT. THE NURSE STATED THAT ONE EMPLOYEES GOT THEIR RIGHT EYE SPLASHED WITH LEVEL 3 OF LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LOT # 27373. THE EYE WAS RINSED OFF. THE EMPLOYEE WAS NOT WEARING PROTECTIVE EYE WEAR. THE EMPLOYEE HAS THE VACCINATION FOR (B)(6). THE NURSE PRACTITIONER WILL DO A BASELINE TESTING AND MAKE DECISION ABOUT STARTING THE EMPLOYEE ON PROPHYLACTIC TREATMENT. THE NURSE INDICATED HAVING A COPY OF THE SDS AND BIO-RAD PROVIDED A COPY OF THE PACKAGE INSERT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9082451 ↗

Other Multi-analyte controls, all kinds (assayed) devices

All Multi-analyte controls, all kinds (assayed) devices →

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