—#108165

Product

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

FDA product code: JGJ — Photometric Method, Magnesium
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K061655
Affected lot / code info: Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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 Rico.

Timeline

Recall initiated: 2012-02-17
Posted by FDA: 2012-04-17
Terminated: 2015-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.