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Terminated

Dimension Vista Ferritin (FERR) Flex reagent cartridge

FDA Recall Z-2609-2017 · Posted 2017-05-05

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeDBF
Date Initiated2017-03-21
Date Terminated2018-08-03
Product Quantity29,266 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070552DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)Dade Behring, Inc. · 2007-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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