The Recall Desk
HighFDA (Devices)·Z-0115-2021·Announced 2020-10-28

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.

What this means for you

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 (01)0063041459916
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard

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.

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