Recall Z-0339-2016
Siemens Healthcare Diagnostics, Inc. · initiated September 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number 15063BA
Reason for recall
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%.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 Medical Director. Siemens will replace any unused inventory of the affected lot.
Details
- Recall number
- Z-0339-2016
- Initiated
- September 30, 2015
- Posted by FDA
- November 25, 2015
- Terminated
- September 1, 2016
- Product code
- JGJ – Photometric Method, Magnesium
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE