Z-2014-2021 Class II Terminated
FDA device recall Z-2014-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on May 18, 2021 and is designated Class II. Reason for recall: ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2… The recall status is terminated (terminated August 30, 2024). Affected quantity: 842 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- May 18, 2021
- Termination Date
- August 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 842 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, MA, MD, MI, MN, NY, OH, PA, TX and the countries of Australia, Bahrain, Brazil, Canada, Chile, Croatia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Portugal, Republic Korea, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.