Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling multiple lots of HER-2/neu assay kits and calibrators used in the Atellica IM and ADVIA Centaur laboratory testing systems. The company confirmed that these products no longer achieve the Upper Limit of Normal (ULN) values stated in the product instructions, which could result in false positive or false negative test results. The affected kits were distributed nationwide, including 135 Atellica IM assay kits, 46 Atellica IM calibrator kits, 1,823 ADVIA Centaur assay kits, and 161 ADVIA Centaur calibrator kits with specific lot numbers and expiration dates ranging from November 2020 through January 2021.
The recall affects specific lot numbers identified by Siemens material numbers, lot codes, and UDI codes listed in the recall notice. The source document does not specify a remedy or recommended action for consumers or healthcare providers who have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
Reason for recall: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results. Distribution: US Nationwide distribution. Quantity: Atellica IM H2n Assay =135 kits; Atellica IM H2n Calibrator = 46 kits; ADVIA Centaur Assay = 1,823 kits; ADVIA Centaur calibrator = 161 kits Lot/code info: Atellica IM HER-2/neu Assay 50 Test Kit: Siemens Material Number (SMN) 10995591; EXP Date 2021-01-30; Lot # 98034139 w/ UDI (01)00630414599151(10)98034139(17)20210130; Lot # 32478139 w/ UDI (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu Calibrator (2 pack): SMN 10995592; EXP Date 2020-12-11; Lot # 22695A49; UDI (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2 Assay 50 Test Kit: SMN 10308994; EXP Date 2021/01/30; Lot # 43157138 w/ UDI (01)00630414471235(10)43157138(17)20210130 ; Lot# 81653138 w/ UDI (01)00630414471235(10)81653138(17)20210130 ; Lot# 99728138 w/ UDI (01)00630414471235(10)99728138(17)20210130 ; Lot # 24043138 w/ UDI (01)00630414471235(10)24043138(17)20210130 ; Lot #32477138 w/ UDI (01)00630414471235(10)32477138(17)20210130 ; ADVIA Centaur HER-2/neu Calibrator (2 pack): SMN 10308993; EXP Date 2020-11-12 Lot # 64661A48 w/ UDI (01)0063041447(10)64661A48(17)20201112 Lot # 81211A48 w/ UDI (01)0063041447(10)81211A48(17)20201112 Lot# 91743A48 w/ UDI (01)0063041447(10)91743A48(17)20201112 EXP Date 2020-12-11; Lot # 22124A49 w/ UDI (01)0063041447(10)22124a49(17)20201112
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.