IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Description of Event or Problem

THE CUSTOMER OBSERVED THAT, WHEN SCANNING THE ALLERGEN HOLDER CONTAINING IMMULITE 2000 3GALLERGY SPECIFIC IGE LOT 171, THE POSITIONS OF THE KITTED COMPONENTS DISPLAYED ON THE SCREEN DO NOT MATCH THE PHYSICAL POSITIONS IN THE ALLERGEN HOLDER. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA AND DID NOT INDICATE THAT ERRONEOUS PATIENT RESULTS WERE OBTAINED. HOWEVER, IF THE ORDER OF THE TUBES WITH THE ALLERGEN HOLDER WEDGE IS INCORRECT, THERE IS A POTENTIAL FOR SAMPLE RESULTS TO BE INACCURATE FOR ANY ALLERGEN LOADED IN THE SAME ALLERGEN HOLDER WEDGE AS IMMULITE 2000 3GALLERGY SPECIFIC IGE LOT 171. IT IS NOT KNOWN IF ANY PATIENT SAMPLES WERE TESTED USING ANY ALLERGEN(S) IN THE SAME ALLERGEN HOLDER WEDGE AS THE 3GALLERGY SPECIFIC IGE ADJUSTOR ANTIBODY (L2UNS1) OR 3GALLERGY SPECIFIC IGE CONTROL ANTIBODY (L2UNS2). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER OBSERVED THAT, WHEN SCANNING THE ALLERGEN HOLDER CONTAINING IMMULITE 2000 3GALLERGY SPECIFIC IGE LOT 171 OR IMMULITE 2000 ALLERGEN-SPECIFIC IGG (SPG) KIT LOT 323, THE POSITIONS OF THE KITTED COMPONENTS DISPLAYED ON THE SCREEN DO NOT MATCH THE PHYSICAL POSITIONS IN THE ALLERGEN HOLDER. IT IS NOT KNOWN IF ANY PATIENT SAMPLES WERE TESTED WHEN 3GALLERGY SPECIFIC LOT 171 WAS LOADED ON THE INSTRUMENT. ON 07-OCT-2025 AN URGENT FIELD SAFETY NOTICE (UFSN IMC26-01A.OUS) WAS SENT TO THE CUSTOMER. THE UFSN EXPLAINED THAT BARCODE ORIENTATION ON THE IMMULITE 3GALLERGY SPECIFIC IGE LOT 171 CAUSES INCORRECT SCANNING ORDER OF TUBES WITHIN THE ALLERGEN HOLDER WEDGE AND THERE IS POTENTIAL FOR PATIENT SAMPLES TO BE INACCURATE FOR ANY ALLERGEN LOADED IN THE ALLERGEN HOLDER WEDGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND DISCARD THE PRODUCT. NOTE: 3GALLERGY SPECIFIC IGE IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10708840. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.