Atellica IM HER-2/neu recall
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and…
Why was Atellica IM HER-2/neu recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- Atellica IM H2n Assay =135 kits; Atellica IM H2n Calibrator = 46 kits; ADVIA Centaur Assay = 1,823 kits; ADVIA Centaur calibrator = 161 kits
- Distribution
- US Nationwide distribution.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)