HEMOSIL SYNTHASIL

Additional Manufacturer Narrative

A REVIEW OF THE CERTIFICATE OF ANALYSIS FOR HEMOSIL SYNTHASIL LOT N0754775 CONFIRMED THE REAGENT MET ALL RELEASE SPECIFICATIONS, WITH NO ABNORMALITIES IDENTIFIED. INSTRUMENT DATA FROM THE ACL TOP 550 CTS (SERIAL NUMBER (B)(6)) SHOWED MULTIPLE ERROR FLAGS DURING THE INITIAL RUN OF SAMPLE ID: (B)(6), INCLUDING PW 5774 (HIL TEST FAILED), SE 5703 (MATERIAL DISPENSE ERROR), HE 5004 (ASPIRATION BASELINE ERROR), AND RE 5100 (MEASURED RESULT FAILED). REPEAT TESTING OF THE SAME SAMPLE PRODUCED APTT-SS RESULTS OF 61.2 SECONDS, 35.5 SECONDS, AND 36.7 SECONDS, WITH ONLY ONE REPEAT FLAGGED FOR PW 5774 (HIL TEST FAILED). CLOT CURVE REVIEW FOR REPEAT RUNS SHOWED NORMAL CURVE MORPHOLOGY WITH NO ABNORMALITIES. QUALITY CONTROL RESULTS (NORMAL CONTROL 1 LOT N0259871 AND ABNORMAL CONTROL 3 LOT N0159179) WERE WITHIN ACCEPTANCE CRITERIA PRIOR TO SAMPLE TESTING. TESTING ON AN ALTERNATE ANALYZER, ACL TOP 750 CTS (SERIAL NUMBER (B)(6)), YIELDED A RESULT OF 36.6 SECONDS WITH NO FLAGS. SERVICE RECORDS INDICATED THAT ON (B)(6) 2026, EXCESSIVE PLAY IN THE CTS Z-AXIS ASSEMBLY AND A CRACKED CTS FOOT WERE IDENTIFIED ON THE ACL TOP 550 CTS. THE COMPONENTS WERE REPLACED, AND PROBE ALIGNMENT WAS SUCCESSFULLY ADJUSTED. POST-SERVICE VERIFICATION CONFIRMED PROPER INSTRUMENT FUNCTION. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE CONFIRMED, THE DISCREPANT INITIAL RESULT IS MOST LIKELY ATTRIBUTED TO THE IDENTIFIED INSTRUMENT FAULTY HARDWARE. NO PATIENT IMPACT HAS BEEN REPORTED. BASED ON THIS ASSESSMENT, NO FURTHER REMEDIAL ACTIONS ARE REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.

Description of Event or Problem

ON (B)(6) 2026, THE CUSTOMER REPORTED THAT POTENTIALLY ERRONEOUS ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT-SS) RESULTS WERE GENERATED FROM ONE PATIENT SAMPLE USING HEMOSIL SYNTHASIL REAGENT (LOT N0754775, PN 00020006800) ON AN ACL TOP 550 CTS ANALYSER (SN (B)(6)). THE RESULTS WERE REPORTED TO THE PATIENT'S CHART, HOWEVER, THERE WAS NO PATIENT IMPACT.