LiquichekRecalls & reported problems across all models

We found 21 models of Liquichek by Bio-Rad Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2017 and Mar 25, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Liquichek problems

Liquichek models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Liquichek 692

  Multi-analyte controls unassayed
  2 reports
• Liquichek 147

  Multi-analyte controls, all kinds (assayed)
  2 reports
• Liquichek 691

  Multi-analyte controls unassayed
  1 report
• Liquichek 148

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 171

  CONTROL, HEMOGLOBIN
  1 report
• Liquichek 360

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 596

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 642

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 547

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 751

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 545X

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 590X

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 750X

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 395X

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 511

  CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
  1 report
• Liquichek 27104

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 27105

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 27113

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 12001084

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 12006239

  Multi-analyte controls, all kinds (assayed)
  1 report
• Liquichek 12006369

  Multi-analyte controls, all kinds (assayed)
  1 report

Recent Liquichek adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, A LABORATORY TECHNICIAN AT (B)(6), LOCATED AT (B)(6), REPORTED AN EYE SPLASH INCIDENT INVOLVING THEMSELVES. THE TECHNICIAN WAS NOT WEARING SAFETY GLASSES WHILE DISCARDING A QC SAMPLE CUP INTO A NEARLY FULL BIOHAZARD BIN. WHEN THE CUP, CONTAINING THE LIQUICHEK IMMUNOLOGY CONTROL QC SAMPLE, BOUNCED BACK AFTER BEING TOSSED, LIQUID SPRAYED INTO THE TECHNICIAN'S LEFT EYE. THE TECHNICIAN IMMEDIATELY RINSED THEIR EYE AT THE EYE WASH STATION. AFTERWARD, THEY CONTACTED THE HOSPITAL AND WERE PRESCRIBED ANTIVIRAL EYE DROPS OVER THE PHONE. NO HARM OR INJURY RESULTED FROM THIS EVENT. THE EMPLOYEE AND FACILITY HAD PRODUCT'S INSTRUCTIONS FOR USE (IFU) AND SAFETY DATA SHEET (SDS) AND WERE PROVIDED INSTRUCTIONS OVER THE PHONE OF HOW TO OBTAIN THE CERTIFICATE OF ANALYSIS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21691818 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON FEBRUARY 12, 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6) USA, REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE AT (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 AT THE TIME OF THE

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21568029 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON FEBRUARY 12, 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6) HOSPITAL (B)(6) REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE AT TRADITION MEDICAL CENTER (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 G

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21567993 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON FEBRUARY 12, 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6) HOSPITAL SOUTH IN (B)(6), USA REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE AT (B)(6) MEDICAL CENTER PORT (B)(6), LOCATED AT (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 P

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21565510 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON FEBRUARY 12, 2025, A CHEMISTRY LAB SUPERVISOR (B)(6) HOSPITAL, (B)(6) REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE (B)(6) CENTER IN (B)(6). ON FEBRUARY 10, 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 W

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21565480 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6). REPORTED AN EYE SPLASHING EVENT ON THEIR (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 AT THE TIME OF THE EVENT. THE EMPLOYEE AND

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21565458 ↗
• 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 ↗
• MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON FEBRUARY 12, 2025, A CHEMISTRY LAB SUPERVISOR AT (B)(6), USA REPORTED AN EYE SPLASHING EVENT ON THEIR COLLEAGUE AT (B)(6). ON FEBRUARY 10, 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 AT THE TIME OF THE EV

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21565399 ↗
• 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 9806104 ↗
• 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 9806100 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 24, 2020Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2020, A MEDICAL TECHNOLOGIST FROM (B)(6) LAB CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT THAT OCCURRED WITH AN EMPLOYEE AT THEIR FACILITY. THE EMPLOYEE WAS OPENING A VIAL OF LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A, LOT # 23694 AND THE CONTENTS SPLASHED ONTO HER RIGHT EYE WHILE NOT WEARING SAFETY GOGGLES. THE EMPLOYEE WASHED AND FLUSHED HER EYES AND ALSO WASHED HER FACE. THE INCIDENT WAS REPORTED TO FACILITIES HEALTH AND THE EMPLOYEE WAS SEEN BY A DOCTOR. NO MEDICAL TESTS WERE DONE. THE EMPLOYEE HAD ALL THE SCREENINGS DONE AT PRE-EMPLOYMENT TIME. THE EMPLOYEE AND FACILITY HAVE ACCESS TO PRODUCT'S PACKAGE INSERT, MSDS AND COA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745217 ↗
• 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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