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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM HER2/neu (H2n) assay and calibrator. ADVIA Centaur HER2/neu (H2n) assay and calibrator

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  Class 2 Device Recall Atellica IM HER2/neu (H2n) assay and calibrator. ADVIA Centaur HER2/neu (H2n) assay and calibrator see related information
Date Initiated by Firm August 25, 2020
Create Date October 16, 2020
Recall Status1 Terminated 3 on March 10, 2023
Recall Number Z-0115-2021
Recall Event ID 86383
510(K)Number K024017  
Product Classification System, test, her-2/neu, monitoring - Product Code NCW
Product 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

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 Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
Code Information 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 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Peter Erickson
508-660-6570
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action All affected customers were sent a letter on 08/25/2020 stating the following: Siemens Healthcare Diagnostics Inc. (Siemens Healthineers) notified customers on August 25th, 2020. Letter states reason for recall, health risk and action to take. Actions to be taken by their customers include: - Reviewing the letter with their Medical Director. - Customers may continue use of the product lots referenced in Table 1 until they receive replacement product in their laboratory. Refer to the Table 3 for product biasinformation. - If you are currently using the products listed in Table1, review your inventory of these products, as well as the associated product QC and MCM, and order replacement products by completing the Field Correction Effectiveness Check Form attached to the letter. - Upon acceptance of the replacement lots referenced in Table 2 New Lot Combinations column, discontinue use of and discard the products listed in Table 2 Current Lot Combinations column. Refer to Figures 1 through 4 for expected results with replacement lots. - Complete and return the Field Correction Effectiveness Check Form attached to this letter. Retain the letter with your laboratory records and forward the letter to those who may have received this product.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NCW and Original Applicant = BAYER CORP.
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