Atellica CH 930 Analyzer — Class II medical device recall Z-0862-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-02-05. On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Techn
| Recall number | Z-0862-2020 |
|---|---|
| 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 | 2019-10-11 |
| Classified | 2020-01-24 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2021-05-03 |
| Countries outside the US | AR, BE, BR, CH, DE, DK, ES, FI, FR, GR, IT, LV, NL, PL, PT, SE, VN |
| Quantity | 1,528 |
| UPC / GTIN / UDI-DI | 00630414002163 |
Product
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
Reason for recall
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
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-0862-2020. 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.