—#113760

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.

FDA product code: JIY — Photometric Method, Iron (Non-Heme)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K061793
Affected lot / code info: Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.

Why it was recalled

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 (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2012-10-08
Posted by FDA: 2012-12-03
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.