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 ↗
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- LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 3 (LIQ CHEM ASY PREMIUM 3) LAE4217Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-303Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- IMMUNOASSAY PREMIUM - TRI-LEVEL (IA PREMIUM 1, 2 AND 3) IA2633Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3) IA2640Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-202Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.