Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No.… recallZ-0115-2021 · Siemens Healthcare Diagnostics, Inc · initiated Aug 25, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0115-2021
- Status
- Terminated
- Initiated by the company
- Aug 25, 2020
- 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
- Product code
- NCW
- FDA submissions
- K024017
- Distribution
- US Nationwide distribution.
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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ADVIA Centaur® H2n 10308994Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, HER-2/NEU, MONITORING1 recall0 reports
- Atellica IM H2n 10995591Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, HER-2/NEU, MONITORING1 recall0 reports
- Atellica IM H2n Calibrator 10995592Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, HER-2/NEU, MONITORING1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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