Recall Z-0452-2013 ยท JIY Photometric Method, Iron (Non-Heme)
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Dec 3, 2012 (initiated Oct 8, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061793 | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR Dade Behring, Inc., Aug 7, 2006 |