Z-0830-2022Class II

Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in...

Name: Z-0830-2022 Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-01-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-01-28 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista... on 2022-01-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0830-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-28
Posted: 2022-03-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
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).
Product code: JGJ Photometric Method, Magnesium
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 root 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 [email protected] 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.
Product codes and lots: [lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA UDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0830-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0830-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-28

Product code JGJ

K140790Class IIDimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics / cleared 2015-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)