Z-2610-2017 Class II Terminated
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
- 3,443 units
Product Description
Dimension Vista Prolactin (PRL) 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.
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
Code Information
Device Listing Number # A836016 Lot # 16112BB, 16148BA,16165BE,16195BA,16223AD,16259BC 16285BE,16312BD,16334BE,17004BA,17038BC