Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Nu

Hazard

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Details from the source

Reason for recall: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Distribution: Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Kenya¿¿¿¿¿¿¿ Quantity: 7,884 kits Lot/code info: UDI: (01)00630414450940(10)16276336 (17)20230320; (01)00630414450940(10)21334336(17)20230320; (01)00630414450940(10)22079336(17)20230320; (01)00630414450940(10)27946338(17)20230529; (01)00630414450940(10)41225342(17)20230630; (01)00630414450940(10)62966344 (17)20230726; Lot Numbers: 16276336, 21334336, 22079336, 27946338, 41225342, 62966344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated.

UPC codes

00630414450940

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.