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.
What this means for you
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 disea
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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
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