Recall Z-0861-2021— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-12-02, terminated 2024-06-06. It names one FDA 510(k) clearance: K151767. Product: 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.. Reason: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-02
- Terminated
- 2024-06-06
- Firm location
- Tarrytown, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Data sourced from openFDA. This site is unofficial and independent of the FDA.