Dimension Vista System recall
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum…
Why was Dimension Vista System recalled?
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%.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 15063BA
- Product
- Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Recall date
- December 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)