Liquichek 147Recalls & reported problems
Bio-Rad Laboratories, Inc. · Liquichek Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.) · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847661000730), received between Mar 9, 2020 and May 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Human-Device Interface Problem1
Patient problems
- Laceration(s)1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2023Burst Container or Vessel; Burst Container or Vessel
ON (B)(6) 2023, AN EMPLOYEE OF SIEMENS HEALTHINEERS REPORTED AN ACCIDENTAL BLOOD EXPOSURE AND FINGER CUT AT LABORATOIRE SYNLAB SYLAB FIGEAC AT COMBE DE LAVAYSSIÈRE, 46100 FIGEAC, FRANCE. THE EMPLOYEE NOTED THAT WHILE OPENING LIQUICHEK CARDIAC MARKER PLUS CONTROL LT, LEVEL 2, LOT 67672 AS PART OF A NEW AUTOMATON INSTALLATION, THE PRODUCT BOTTLE BURST AND CAUSED CUTS TO THE LEFT INDEX FINGER. A 5-DAY OF ANTIBIOTICS DOSE WAS GIVEN AND TESTS FOR HIV, HCV, AGHBS, AND SYPHILIS WERE CONDUCTED. BIO-RAD TECHNICAL SERVICE PROVIDED THE PRODUCT SAFETY DATA SHEET, AS WELL AS THE INSTRUCTIONS FOR USE (IFU) AND CERTIFICATE OF ANALYSIS FOR LOT 67672.
Patient problems: Laceration(s)
MAUDE report 16947420 ↗MalfunctionMar 9, 2020Human-Device Interface Problem; Human-Device Interface Problem
ON (B)(6) 2020, A LABORATORY INFORMATION MANAGER FROM (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 SPLASHED 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 AND CERTIFICATE OF ANA
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9806096 ↗
Other Multi-analyte controls, all kinds (assayed) devices
- LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL LAE4215Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- Dried Blood Control 0193Chromsystems Instruments + Chemicals GmbH · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-SPMicrogenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- 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.