Atellica CH 930 Analyzer — Class II medical device recall Z-1797-2020

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-05-06, distributed nationwide. Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the ch

Recall number	`Z-1797-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States
Recall initiated	2020-02-27
Classified	2020-04-24
Reported by FDA	2020-05-06
Terminated	2021-10-25
Distributed	Nationwide (US)
Quantity	1,807
Reason classes	potency
UPC / GTIN / UDI-DI	`00630414002163`
Serial numbers	`CM00117`, `CM00123`, `CM00125`, `CM00130`, `CM00131`, `CM00132`, `CM00133`, `CM00134`, `CM00135`, `CM00136`, `CM00137`, `CM00139`, `CM00140`, `CM00141`, `CM00143`, `CM00145`, `CM00146`, `CM00147`, `CM00148`, `CM00149`, `CM00150`, `CM00151`, `CM00152`, `CM00153`, `CM00154` and 475 more

Product

Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

Reason for recall

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1797-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.