SAFE-T-FILL WHOLE BLOOD 125UL

Description of Event or Problem

FALSELY ELEVATED CAPILLARY LEAD RESULTS FROM USING COLLECTING CAPILLARY BLOOD INTO EDTA SAFE-T-FILL 125UL TUBES (LOT # 24H4121 EX 8.31.26, 24E4139 EXP 5.31.26, 24H421 EXP 8.31.26). THE VENDOR IS (B)(4). WE TEST THIS BLOOD ON THE MERIDIAN LEADCARE II. WE HAVE REPEATED THE SAME PATIENTS USING THE CAPILLARY TUBES CONTAINED IN THE MERIDIAN KITS, AND WE GET NORMAL (LOW: <3.3MG/DL) RESULTS. WE ALSO HAD OUR OTHER LAB RUN THE SAME SAMPLES ON THEIR LEAD CARE INSTRUMENT AND GOT THE SAME RESULTS. IN (B)(4) I REACHED OUT TO THE VENDOR, AND WE DID SEND THEM BACK SOME OF THE TUBES WE HAD ON-HAND. BUT IN (B)(6) 2024, WE NOTICED IT OCCURRING AGAIN. I HAVE EMAILED THEM A FEW TIMES REGARDING THIS ISSUE WITH NO HELP. WE HAVE PULLED AND NO LONGER ARE USING THESE LOT NUMBERS FROM OUR STOCK. 2 KNOWN PATIENTS RETURNED FOR A VENOUS DRAWN AND SEND TO LABCORP FOR TESTING, BOTH RESULTS CAME BACK AS <1 (NEGATIVE). REFERENCE REPORTS: MW5164872, MW5164873.