—#183649

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.

FDA product code: NCW — System, Test, Her-2/Neu, Monitoring
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K024017
Affected 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

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-08-25
Terminated: 2023-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183649. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.