Reported Oct 28, 2020 · Terminated
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
Atellica IM HER-2/neu (H2n) assay50 Test KitCatalog 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 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994
- UDI codes(01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993
- UDI Codes(01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211
- Product UsageThis product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay
- Lot codes and dates
16 of 16 products
Products covered by this recall # Barcodes Product as published 1 Siemens Material Number (SMN) 10995591 2 EXP Date 2021-01-30 3 00630414599151Lot # 98034139 w/ UDI (01)00630414599151(10)98034139(17)20210130 4 00630414599151Lot # 32478139 w/ UDI (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu Calibrator (2 pack): SMN 10995592 5 EXP Date 2020-12-11 6 Lot # 22695A49 7 00630414599168UDI (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2 Assay 50 Test Kit: SMN 10308994 8 EXP Date 2021/01/30 9 00630414471235Lot # 43157138 w/ UDI (01)00630414471235(10)43157138(17)20210130 10 00630414471235Lot# 81653138 w/ UDI (01)00630414471235(10)81653138(17)20210130 11 00630414471235Lot# 99728138 w/ UDI (01)00630414471235(10)99728138(17)20210130 12 00630414471235Lot # 24043138 w/ UDI (01)00630414471235(10)24043138(17)20210130 13 00630414471235Lot #32477138 w/ UDI (01)00630414471235(10)32477138(17)20210130 14 ADVIA Centaur HER-2/neu Calibrator (2 pack): SMN 10308993 15 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 16 Lot # 22124A49 w/ UDI (01)0063041447(10)22124a49(17)20201112 - Amount recalled
- Atellica IM H2n Assay =135 kits; Atellica IM H2n Calibrator = 46 kits; ADVIA Centaur Assay = 1,823 kits; ADVIA Centaur calibrator = 161 kits
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Healthcare Diagnostics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.