Additional Manufacturer Narrative · 1
THE ORTHO SUMMIT PLUS IS THE HAMILTON MICROLAB AT PLUS 2 PIPETTER PRIVATE LABELED AND DISTRIBUTED BY ORTHO-CLINICAL DIAGNOSTICS INTO THE OTHER COUNTRYS. THE MICROLAB AT PLUS 2 IS A "SECOND GENERATION" MICROLAB AT PIPETTER FROM ANOTHER COUNTRY'S MFR. THE MICROLAB AT PIPETTER IS THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM IN THE UNITED STATES. BOTH PIPETTERS USE THE SAME HAMILTON (LABELED) DISPOSABLE PIPETTER TIPS. THE OPERATING SOFTWARE FOR THE PIPETTERS IS DIFFERENT. CUSTOMER REPORTED THAT THE ORTHO SUMMIT SAMPLER INSTALLED IN THEIR LAB HAD FAILED TO DISPENSE THE DILUENT AS EXPECTED WITHOUT GENERATING AN ALARM. FAILURE OCCURRED TWICE WHILE PIPETTING HTLV ASSAY. ON THE FIRST FAILURE, THE DILUENT WAS NOT DISPENSED ON ROW 11 AND ON THE SECOND FAILURE, THE DILUENT WAS NOT OR PARTIALLY DISPENSED ON ROW 10 AND 12. THE CUSTOMER INDICATED THAT NO BIASED RESULTS WERE GENERATED AND/OR REPORTED TO THE PHYSICIAN. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENTS AND FOUND THE PRESENCE OF LIQUID ON THE DETECTION BOARD UNDER THE DILUENT RACKS INSTRUMENT WAS CLEANED AND TESTED WITHOUT FURTHER PROBLEM. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION.