Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results
Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential false positive or negative diagnostic results, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of Atellica IM HER-2/neu (H2n) assay kits, Atellica IM HER-2/neu (H2n) calibrators, ADVIA Centaur HER-2/neu (H2n) assay kits, and ADVIA Centaur HER-2/neu (H2n) calibrators. The recall covers 135 Atellica IM assay kits, 46 Atellica IM calibrator kits, 1,823 ADVIA Centaur assay kits, and 161 ADVIA Centaur calibrator kits. These products were distributed nationwide in the United States.
The recall was initiated because Siemens confirmed that the Upper Limit of Normal (ULN) claimed in the Instructions for Use was no longer achieved. This defect can potentially result in false positive or false negative test results. The affected products are intended for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
Healthcare facilities and laboratories should stop using the affected lots immediately and contact Siemens Healthcare Diagnostics for further instructions on returning or disposing of the products. Patients who have received test results using these specific kits should consult their healthcare provider to discuss the potential impact on their diagnosis or treatment plan.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
- EXP Date 2020-12-11
- Lot # 22695A49
- 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
- Lot # 22124A49 w/ UDI (01)0063041447(10)22124a49(17)20201112
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · false positive
See all →- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- HighSiemens Atellica IM CKMB Calibrator Recalled for Potential Bias
FDA (Devices) · 2018-10-24
- ModerateSiemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery
FDA (Devices) · 2018-05-02
- LowSiemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy
FDA (Devices) · 2013-08-21
- ModerateSiemens Recalls Insulin Calibrators Due to Measurement Deviation
FDA (Devices) · 2017-05-24
- ModerateSiemens Atellica IM aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08
- SevereSiemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
FDA (Devices) · 2014-07-09