Recall Z-1433-2012 ยท JGJ Photometric Method, Magnesium
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
| Date | Apr 17, 2012 (initiated Feb 17, 2012) |
| Status | Terminated |
| Reason | Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299. |
| Quantity | 9,178 |
| Distribution | Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES Dade Behring, Inc., Jul 10, 2006 |