Recall Z-2608-2017— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-03-21, terminated 2018-08-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Dimension Vista Estradiol (E2) Flex reagent cartridge. Reason: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-21
- Terminated
- 2018-08-03
- Firm location
- Newark, DE, United States
Product description
Dimension Vista Estradiol (E2) Flex reagent cartridge
Reason for recall
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Data sourced from openFDA. This site is unofficial and independent of the FDA.