Z-0830-2020 Class II Terminated
FDA device recall Z-0830-2020 was initiated by Siemens Healthcare Diagnostics, Inc on July 22, 2019 and is designated Class II. Reason for recall: Homocysteine Assay May Cause Elevated Results in the Folate Assay The recall status is terminated (terminated February 14, 2025). Affected quantity: 10,928 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- July 22, 2019
- Termination Date
- February 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,928 kits
Product Description
Reason for Recall
Distribution Pattern
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