Agency classClass IIOur severity:High FDA (Devices)·Z-0452-2013·Announced 2012-12-12

Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results

Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that can produce inaccurate diagnostic results (falsely elevated iron levels), which poses a risk of harm through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 19,310 units of Dimension Vista IRON Flex reagent cartridges (K3085). The recall covers specific lot numbers including 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC, and 12188BD. These products were distributed worldwide, including in the United States, Canada, Australia, New Zealand, Japan, Germany, Saudi Arabia, and Malaysia.

The recall was initiated because the reagent cartridges have the potential to produce falsely elevated results when processed from a well set contaminated with iron from environmental sources. If a well set is contaminated with trace amounts of iron, the entire well set is impacted. The source text notes that all lots of IRON Flex reagent cartridges have the potential for this issue.

The IRON method is an in vitro diagnostic test used for the quantitative determination of iron in human serum and plasma. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism. Users should contact Siemens Healthcare Diagnostics for further instructions on handling the affected units.

The recalled product

Product: Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic Reagents
Hazard: mis-diagnosis
inaccurate-results
Affected units: 19,310

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

Lot numbers 11286BA
11319BB
12004BB
12044BC
12073BB
12073BC
12101BC
12101BD
12130BB
12130BC and 12188BD.

Distribution

Distributed in 46 states:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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