Z-0157-2020 Class II Terminated
FDA device recall Z-0157-2020 was initiated by Vital Scientific N.V. on January 10, 2012 and is designated Class II. Reason for recall: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. The recall status is terminated (terminated April 19, 2024). Affected quantity: 5 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- January 10, 2012
- Termination Date
- April 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 instruments
Product Description
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Reason for Recall
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Distribution Pattern
US Nationwide in the states of NY, and UT
Code Information
serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.