Recall Z-0339-2016 ยท JGJ Photometric Method, Magnesium
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
| Date | Nov 25, 2015 (initiated Sep 30, 2015) |
| Status | Terminated |
| Reason | Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers. 1. An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following: Siemens has received customer complaints for Dimension Vista MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results. Discontinue use and discard their remaining inventory of the affected lot. Review the letter with their Med |
| Quantity | 3601 |
| Distribution | Distributed US (nationwide) including DC and the states of IL, CA, GA, LA, TX, TN, FL, SC, IA, TN, DE, NJ, WA, MS, KY, NY, WI, OH, OH, MO, UT, KS, VA, AR, WV, MA, PA, AL, CO, IN, MT, NM, ME, AZ, NM, MO, and NC, and the country of Canada. |
| 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 |