Description of Event or Problem · 0
CUSTOMER NOTIFIED TECHNICAL SERVICES VIA EMAIL THAT, FOR THE LAST FEW WEEKS, ALL PATIENT RESULTS HAVE BEEN READING LOW. CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION ON 11-DEC-1015, 17-DEC-1015,AND ON 22-DEC-2025 WAS REACHED. CUSTOMER REPORTED, WHEN THE 3-5 MOST RECENT PATIENT SAMPLES WERE TESTED ON THE LEADCARE II TEST SYSTEM, THE ANALYZER DISPLAYED RESULTS AS "LOW", OR < 3.3 UG/DL. PATIENTS WERE SENT FOR CONFIRMATION TESTING; HOWEVER, THE CUSTOMER DID NOT PROVIDE THE CONFIRMATORY TEST RESULTS AS REQUESTED. NO PATIENT INJURY OR HARM WAS REPORTED BY CUSTOMER. CUSTOMER REPORTED THAT FOLLOWING THE LOW RESULTS THEY RAN CONTROLS MULTIPLE TIMES AND THE RESULTS WERE DISPLAYED ON THE ANALYZER AS "LOW" OR < 3.3 UG/DL. TECHNICAL SERVICES INSTRUCTED CUSTOMER NOT TO USE THIS TEST KIT FOR PATIENT TESTING IF THE CONTROL VALUES WERE NOT IN RANGE. TECHNICAL SERVICES SENT A REPLACEMENT TEST KIT, AND THE CUSTOMER WILL RETURN THE AFFECTED KIT FOR FURTHER INVESTIGATION. AS OF THE DATE OF THIS REPORT, RECEIPT OF THE KIT IS PENDING. TECHNICAL SERVICES ALSO INSTRUCTED CUSTOMER TO INSPECT THE METAL PINS ON THE ANALYZER SENSOR DECK. CUSTOMER REPORTED THAT ALL 5 SENSOR PINS APPEARED GOLD AND IN GOOD CONDITION. TECHNICAL SERVICES ASKED CUSTOMER TO DESCRIBE THEIR METHOD FOR BLOOD LEAD CAPILLARY COLLECTION AND DETERMINED THAT THE CUSTOMER DID NOT FOLLOW INSTRUCTIONS STATED IN THE PRODUCT PACKAGE INSERT. CUSTOMER WAS INSTRUCTED TO FOLLOW CDC GUIDELINES FOR CAPILLARY BLOOD COLLECTION, AND WAS ALSO PROVIDED WITH THE LINK TO THE FDA SAFETY COMMUNICATION REGARDING USE OF RAM SAFE-T-FILL TUBES, ALTHOUGH CUSTOMER STATED THAT THE CAPILLARY TUBES SUPPLIED WITH THE TEST KIT WERE USED FOR PATIENT SAMPLE COLLECTION. ON (B)(6) 2026, CUSTOMER CONFIRMED RECEIPT OF THE REPLACEMENT TEST KIT AND REPORTED CONTROLS WERE IN RANGE USING THE REPLACEMENT KIT.