LYPHOCHEK IMMUNOASSAY PLUS CONTROL MINIPAK

Description of Event or Problem

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 (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 FACILITY HAD PRODUCT'S INSTRUCTIONS FOR USE (IFU) AND SAFETY DATA SHEET (SDS) AND WERE PROVIDED WITH CERTIFICATE OF ANALYSIS FOR ALL THESE PRODUCTS.

Additional Manufacturer Narrative

INSTRUCTION FOR USE (IFU) PROVIDED BY BIO-RAD FOR TESTING LYPHOCHEK IMMUNOASSAY PLUS CONTROL INDICATES THAT THE PRODUCT CONTAINS HUMAN SOURCE MATERIALS AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS IN ACCORDANCE WITH GOOD LABORATORY PRACTICE. EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS PRODUCT WAS TESTED AS REQUIRED BY FDA ACCEPTED METHODS. TESTS 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 TESTS. IN ACCORDANCE WITH GOOD LABORATORY PRACTICE, ALL HUMAN SOURCE MATERIAL SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS.