Z-2026-2021Class II

Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN...

Name: Z-2026-2021 Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-05-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-05-13 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000 on 2021-05-13. FDA classified it as Class II and gives the reason as "Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2026-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-13
Posted: 2021-07-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021. Letter states: Actions to be Taken by the Customer The following actions must be taken until your system has been serviced to replace any leaking components. 1. When reporting results, ensure that all QC results are within the laboratory acceptable range before releasing results. A manufacturing defect in some valves may cause them to leak Siemens Healthcare Diagnostics Inc. 2. On the Atellica CH930 Analyzer: If any water droplets are observed on the tips of any Reaction Wash Station or Dilution Wash Station probes, contact Siemens service so that the instrument can be checked for valves that may be failing. 3. On the Atellica IM 1300 or Atellica IM 1600 Analyzers: If any water droplets are observed forming at the tips of any Reagent probes, contact Siemens service so that the instrument can be checked for valves that may be failing. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Technical Support representative. Siemens Service representative will be contacting your laboratory to check and replace the identified valves. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or y
Quantity in commerce: US: 210 OUS: 874
Distribution: Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R. China Pakistan Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. Uganda Ukraine United Kingdom Uruguay Vatikancity Vietnam
Product codes and lots: Effected SN Range: CM00902 - CM02065 Note: xxxx in serial number is any number. UDI: 00630414002163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2026-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2026-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-07
Z-2027-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-07
Z-2028-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-14	2021-07-07

Product code JGS

K151767Class IITrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2015-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)