Z-0452-2013Class II

Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for...

Name: Z-0452-2013 Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-10-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-10-08 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2012-10-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0452-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-08
Posted: 2012-12-03
Terminated: 2014-01-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
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 diseases such as iron deficiency anemia and other disorders of iron metabolism.
Product code: JIY Photometric Method, Iron (Non-Heme)
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm intiated their recall of the specified lots on October 8, 2012 by issuing a letter to all consignees informing them of the problems with the reagent cartridges. Firm recommended batching the processing of the tests on one instrument and provided instructions to disable normal flow of IRON and to run the QC on each IRON Flex(R) reagent cartridge well set. In addition, a a reply form and Frequently Asked Questions attachment were enclosed with the communication. For questions regarding this recall call 302-631-6311.
Quantity in commerce: 19,310
Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY
Product codes and lots: Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0452-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

Product code JIY

K061793Class IDimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. / cleared 2006-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)