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

Agency Publication Date: February 21, 2023

Affected Products

Product: Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

(01)00630414598963(10)15308337(17)20230320 (01)00630414598963(10)27949339(17)20230529 (01)00630414598963(10)41143343(17)20230630 (01)00630414598963(10)41144343(17)20230630 (01)00630414598963(10)62969345(17)20230726 Lot Numbers: 15308337, 27949339, 41143343, 41144343, 62969345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.

Lot Numbers:

Numbers

Product: Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

UDI: (01)00630414598970(10)15307337(17)20230320; (01)00630414598970(10)27948339(17)20230529; (01)00630414598970(10)41142343(17)20230630; (01)00630414598970(10)62968345(17)20230726. Lot Numbers: 15307337, 27948339, 41142343, 62968345 and higher. All current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated

Lot Numbers:

Numbers

Product: Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

UDI: (01)00630414293653(10)16097337(17)20230320 (01)00630414293653(10) 44861343 (17)20230630 (01)00630414293653(10) 63869345 (17)20230726 Lot Numbers: 16097337, 44861343, 63869345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.

Lot Numbers:

Numbers

Product: ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308

UDI: (01)00630414204192(10)16275336(17)20230320; (01)00630414204192(10)21333336(17)20230320; (01)00630414204192(10)22318336(17)20230320; (01)00630414204192(10)23066336(17)20230320; (01)00630414204192(10)27947338(17)20230529; (01)00630414204192(10)62967344(17)20230726. Lot Numbers: 16275336, 21333336, 22318336, 23066336, 27947338, 62967344 and higher. Affects all current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated

Lot Numbers:

Numbers

Product: 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 Number (SMN): 10325366

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.

Lot Numbers:

Numbers

Product: ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366

UDI: (01)00630414454597(10) 16277336(17)20230320; (01)00630414454597(10) 23278336 (17)20230320; (01)00630414454597(10)25958336(17)20230320; (01)00630414454597(10)63092344(17)20230726. Lot Numbers: 16277336, 23278336, 25958336, 63092344 and higher. Affects all current and future lots of the Advia Centaur Folate assay until the Instructions for Use are updated.

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91522

Status: Active

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Manufactured In: United States

Units Affected: 6 products (13,843 kits; 9,272 kits; 1,865 kits; 14,669 kits; 7,884 kits; 124 kits)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

Lot Numbers:

Numbers

Product: Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

Lot Numbers:

Numbers

Product: Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

Lot Numbers:

Numbers

Product: ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308

Lot Numbers:

Numbers

Product: 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 Number (SMN): 10325366

Lot Numbers:

Numbers

Lot Numbers:

Numbers