Recall Z-0148-2020
Siemens Healthcare Diagnostics, Inc. · initiated July 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Codes / lots: Software version: V1.19.2 and below
Reason for recall
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
FDA-determined cause: Software design
Action taken
Siemens issued an Urgent medical Device Correction, (UMDC ASI19-02.A.US) via Fed Ex and Urgent Field Safety Notification (UFSN ASI19-02.A.OUS) to all affected Customers beginning on 2019-07-30. The UFSN/UMDC explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email within 30 days. Field Service personnel will be sent a Service Knowledge Base describing the issue and instructing them how to deal with customer questions.
Details
- Recall number
- Z-0148-2020
- Initiated
- July 30, 2019
- Terminated
- June 10, 2022
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Quantity
- 1125 units
- Distribution
- Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY