Z-0148-2020 Class II Terminated
FDA device recall Z-0148-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on July 30, 2019 and is designated Class II. Reason for recall: Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below The recall status is terminated (terminated June 10, 2022). Affected quantity: 1125 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- July 30, 2019
- Termination Date
- June 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1125 units
Product Description
Reason for Recall
Distribution Pattern
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 Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam