Class 2 Device Recall Dimension Vista Magnesium (MG) Flex Reagent Cartridge

• Date Initiated by Firm: January 28, 2022
• Create Date: March 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0830-2022
• Recall Event ID: 89697
• 510(K)Number: K140790
• Product Classification: Photometric method, magnesium - Product Code JGJ
• 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).
• Code Information: [lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA UDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr; Newark DE 19702-2466
• For Additional Information Contact: Siemens Healthineers Remote Services Center; 800-441-9250
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 14220 (US 13305, OUS 915)
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JGJ