CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
Atellica CH 930 Analyzer, Siemens Material Number recalled
Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzer, Siemens Material Number 11067000. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0862-2020
- FDA event ID
- 84281
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2019
- FDA classified
- 24 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Oct 2019 | Recall initiated by company | |
| 24 Jan 2020 | Classified by FDA | +105 days |
| 5 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: 00630414002163, Software Versions V1.19.2 or 1.20.0 when used with languages (countries) that use a comma delimiter instead of a decimal separator (i.e. 1,02 vs 1.02), AND when scanning barcodes at the module console.
Where was it sold?
The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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