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Terminated

Dimension Vista IRON Flex reagent cartridges

FDA Recall Z-0401-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIY
Date Initiated2016-08-25
Date Terminated2017-12-01
Product Quantity30,247 units

Reason for Recall

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

Firm Action

Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.

Root Cause

Error in labeling

Distribution Pattern

Distributed Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc. · 2006-03-08

Official Source

View FDA Recall →

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

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