BABSON SAMPLE PREPARATION DEVICE

Description of Event or Problem

ON (B)(6) 2026, A CUSTOMER'S SAMPLE WAS NOT PROCESSED BY THE BABSON SAMPLE PREPARATION DEVICE (SPD) ON ORDER (B)(4) (SAMPLE ID (B)(6)) DUE TO USE ERROR. THE SAMPLE WAS NOT CENTRIFUGED IN A TIMELY MANNER BECAUSE THE SAMPLE CADDY WAS IMPROPERLY DOCKED BY THE USER. THE CUSTOMER'S SAMPLE WAS BROUGHT BACK TO THE LABORATORY THAT SAME DAY; HOWEVER, THE SAMPLE WAS DEEMED UNVIABLE AND COULD NOT BE PROCESSED. THE CUSTOMER WAS NOTIFIED OF TESTS NOT PERFORMED ON (B)(6) 2026. CUSTOMER WAS OFFERED A RECOLLECTION, WHICH THE CUSTOMER DID NOT ACCEPT. A REFUND WAS PROCESSED PER CUSTOMER'S REQUEST. CUSTOMER DID NOT REPORT SERIOUS INJURY OR ILLNESS AS A RESULT OF THIS EVENT. THERE WERE NO CUSTOMER ADVERSE EVENTS. MITIGATIONS ARE PUT IN PLACE TO ENHANCE INTERNAL MONITORING OF ISSUES IN THE FIELD FOR A TIMELY RESPONSE.