Product Description
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.
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.
Action Details
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.
Distribution Pattern
US Nationwide distribution.
Code Information / Serial Numbers
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
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.