Z-2608-2017 Class II Terminated
FDA device recall Z-2608-2017 was initiated by Siemens Healthcare Diagnostics, Inc. on March 21, 2017 and is designated Class II. 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, FE… The recall status is terminated (terminated August 3, 2018). Affected quantity: 1,697 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2017
- Initiation Date
- March 21, 2017
- Termination Date
- August 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,697 units
Product Description
Reason for Recall
Distribution Pattern
Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa