LIQUICHEK ETHANOL/AMMONIA CONTROL MINIPAK
Received Mar 10, 2025 · Event occurred Feb 10, 2025
Report 2016706-2025-00001 · MDR key 21565480
Device
Generic name
Multi-analyte Controls, All Kinds (assayed)
Manufacturer
Bio-rad Laboratories, Inc.Catalog number
545X
Lot number
54430
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- Unspecified Eye / Vision Problem
- Unspecified Eye / Vision Problem
Narrative
Additional Manufacturer Narrative
INSTRUCTION FOR USE (IFU) PROVIDED BY BIO-RAD FOR TESTING LIQUICHEK ETHANOL/AMMONIA CONTROL INDICATES 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. THE LABELING AND THE SAFETY DATA SHEET (SDS) CONTAIN THE APPROPRIATE HAZARD WARNINGS FOR 5-CHLORO-2-METHYL-2H-ISOTHIAZOL-3-ONE. THE IFU ALSO INDICATED THAT THIS PRODUCT IS PREPARED FROM BOVINE SERUM ALBUMIN AND THE CERTIFICATE OF ANALYSIS STATES THAT "THE BOVINE SOURCE MATERIAL(S) OF THIS PRODUCT IS COLLECTED IN USDA LICENSED ESTABLISHMENTS. THESE ANIMALS RECEIVED ANTE AND POST MORTEM INSPECTION AT THE ABATTOIR BY A US VETERINARY SERVICE INSPECTOR".
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 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 EVENT. THE EMPLOYEE AND FACILITY HAD PRODUCT INSTRUCTIONS FOR USE (IFU) AND SAFETY DATA SHEET (SDS) AND WERE PROVIDED WITH CERTIFICATE OF ANALYSIS FOR ALL THESE PRODUCTS.