BIO-RAD

Additional Manufacturer Narrative

THIS IS OUR COMBINED INITIAL AND FINAL REPORT FOR THIS INCIDENT.

Description of Event or Problem

A IH-LISS RACK WITH ONE WELL THAT APPEARS YELLOWISH IN COLOR. IT WAS REQUESTED TO THE CUSTOMER TO SEND BACK THE IH-LISS RACK. THE CUSTOMER INDICATED THEY HAD ALREADY PIERCED THE WELL TO CONDUCT THEIR OWN INTERNAL TESTING. THE CUSTOMER ASKED WHETHER THE DISCOLORATION COULD BE CONTRIBUTING TO THE FALSE POSITIVE ANTI-B RESULTS. AS PART OF THEIR INTERNAL REVIEW, THEY PREPARED TWO CELL SUSPENSIONS USING A NON-TRANSFUSED GROUP O PATIENT: ONE WITH THE DISCOLORED LISS AND ONE WITH A NON-DISCOLORED LISS. ABO TYPING WAS PERFORMED USING GEL CARDS. THE PATIENT TYPED AS GROUP O, AND NO ANTI-B REACTIVITY WAS OBSERVED IN THE GEL CARD WELLS. HOWEVER, THE TECHNOLOGIST PERFORMING THE TESTING NOTED WHAT APPEARED TO BE DEBRIS OR PARTICULATES IN THE GEL CARD WHEN USING THE DISCOLORED LISS. I ASKED THE CUSTOMER WHETHER ANY DISCOLORED IH-LISS RACKS HAD BEEN USED WITH THE SAMPLES THAT PRODUCED THE FALSE POSITIVE ANTI-B REACTIONS. THE CUSTOMER STATED THEY WOULD NOT USE A RACK SHOWING DISCOLORATION FOR PATIENT TESTING. HOWEVER, THEY ALSO ACKNOWLEDGED THEY DO NOT ROUTINELY PERFORM A VISUAL INSPECTION ON EVERY IH-LISS RACK LOADED ONTO THE IH-1000 INSTRUMENTS. THE CUSTOMER REPORTED THAT THEY INSPECTED THE REMAINING IH-LISS RACKS STORED IN THE REFRIGERATOR AND DID NOT OBSERVE ANY DISCOLORATION. OTHER IH-LISS RACKS WERE CHECKED AND IT WAS NOT NOTICED ANY DISCOLORATION IN ANY WELLS. THE SNAPSHOTS PROVIDED DIDN'T SHOWS ANY ISSUE CONCERNING THIS SAMPLES. THE CUSTOMER PERFOMED TESTING WITH THE YELLOW WELL AND NOTICED THE SAME FALSE-POSITIVE RESULTS. WE CANNOT IDENTIFY ANY OTHER REASON THAT WOULD EXPLAIN THESE RESULTS. WE WERE NOT ABLE TO REPRODUCE THE ISSUE IN OUR LABORATORY. WE ALSO CHECKED THE IH-LISS RETENTION SAMPLES IN DREIEICH, AND AMONG THE 34 BOXES CURRENTLY IN THE REFERENCE STOCK, NO WELLS WITH ABNORMAL COLORATION WERE OBSERVED. THIS LEADS US TO BELIEVE THAT THIS IS AN ISOLATED CASE, AND WE ARE NOT ABLE TO LINK IT TO MANUFACTURING. FOR IH-LISS, IT IS SPECIFICALLY INDICATED NOT TO USE THE PRODUCT IN CASE OF TURBIDITY; THIS ALSO APPLIES WHEN THERE ARE VISIBLE COLOR DIFFERENCES IN THE WELLS. IN THIS CONTEXT, OUR RECOMMENDATION IS TO VISUALLY CHECK THE IH-LISS BEFORE LOADING IT ONTO THE DEVICES, AND IF ANY TURBIDITY OR DISCOLORATION IS OBSERVED, TESTING WITH THAT RACK SHOULD NOT BE PERFORMED. IF THIS SITUATION OCCURS AGAIN, THE RACK SHOULD BE RETURNED UNUSED TO BIO-RAD DREIECH SO THAT WE CAN PERFORM FURTHER ANALYSES.