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

FDA device recall Z-0452-2013 · posted 2012-12-03 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JIY

Quantity affected

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

Date initiated

2012-10-08

Date posted

2012-12-03

Date terminated

2014-01-14

Location

Newark, DE

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