Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determin...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0452-2013.
Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the mag
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0452-2013.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0452-2013.
Siemens Healthcare Diagnostics, Inc.
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Siemens Healthcare Diagnostics, Inc. Recall FAQ
Siemens Healthcare Diagnostics, Inc. is the subject of a diagnostic devices safety report: Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determin.... The notice was published on October 8, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 19,310 units are potentially affected.