# FDA recall Z-0115-2021

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2020-08-25.

## 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

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0115-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-25
- **Report date:** 2020-10-28
- **Termination date:** 2023-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2021

## Citation

> AI Analytics. FDA recall Z-0115-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0115-2021. Source: US FDA. Licensed CC0.

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