Dimension Vista Prolactin (PRL) Flex reagent cartridge
FDA Recall Z-2610-2017 · Posted 2017-05-05
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCFT
Date Initiated2017-03-21
Date Terminated2018-08-03
Product Quantity3,443 units
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.
Firm Action
Siemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer.
Root Cause
Under Investigation by firm
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.