Recall Z-0861-2021 · JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
| Date | Dec 2, 2020 |
| Status | Terminated |
| Reason | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| Root cause | Under Investigation by firm |
| Action | Siemens has issued an Urgent Medical Device Correction letter (UMDC ASW21-02.A.US) and Urgent Field Safety Notice, (UFSN ASW21-02.A.OUS) to all affected Customers stating reason for recall, health risk and action to take: Software version 1.24.x correcting the issues will be released when available and all systems will be updated. The following actions must be taken until your system has been updated to software version 1.24 or higher which resolves the issues listed below. Siemens Healthineers will notify you when an updated software version is available. Issue Number 1: Patient sample may |
| Quantity | 2405 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc., Dec 11, 2015 |