LIQUICHEK IMMUNOLOGY CONTROL LEVEL 3

Description of Event or Problem

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.

Additional Manufacturer Narrative

INSTRUCTION FOR USE (IFU) PROVIDED BY BIO-RAD FOR TESTING LIQUICHEK IMMUNOLOGY CONTROL INDICATES THE PRODUCT CONTAINS HUMAN SOURCE MATERIALS AND SHOULD BE CONSIDERED AS POTENTIALLY INFECTIOUS AND HANDLED WITH GOOD LABORATORY PRACTICE. EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS PRODUCT WAS TESTED AS REQUIRED BY FDA ACCEPTED METHODS. TEST RESULTS WERE NON-REACTIVE OR NEGATIVE FOR EVIDENCE OF INFECTION DUE TO HUMAN IMMUNODEFICIENCY VIRUS (HIV), HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV). THIS PRODUCT MAY ALSO CONTAIN OTHER HUMAN SOURCE MATERIALS FOR WHICH THERE ARE NO APPROVED TEST. IN ACCORDANCE WITH GOOD LABORATORY PRACTICE, ALL HUMAN SOURCE MATERIALS SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS. THE IFU OF LIQUICHEK IMMUNOLOGY CONTROL INDICATE THAT CAUTION SHOULD BE USED WHEN HANDLING THIS PRODUCT TO PREVENT SPLASHING AND INSTRUCTS THE USER TO WEAR APPROPRIATE EYE/FACE PROTECTION WHEN USING THIS PRODUCT TO PROTECT FROM SPLASHES.