—#192233

Product

Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).

FDA product code: JGJ — Photometric Method, Magnesium
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K140790
Affected lot / code info: [lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA UDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]

Why it was recalled

Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Siemens Healthineers, sent "URGENT MEDICAL DEVICE CORRECTION" (VC-22-01.A.US) on 01/28/2022 via Fed Ex to all customers to inform them of the issue and instruct them to discontinue use and discard the affected lots. Complete and return the Field Correction Effectiveness Check Form via email at uscctsfcaecfax.team@siemens-healthineers.com or fax to: (312) 275-7795. At the present time, Siemens has no replacement lots to offer customers. Siemens suggests using an alternate methodology for magnesium until a replacement lot is available. If you received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Replacement kits will be provided when a new lot is available. If you have any questions, please contact your Siemens Healthineers Remote Services Center or your local Siemens Healthineers Technical Support Representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, 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, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY) and OUS countries of: Australia, Canada and Netherlands.

Timeline

Recall initiated: 2022-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192233. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.