Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0830-2022

Z-0830-2022 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

FDA device recall Z-0830-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Jan 28, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 14220 (US 13305, OUS 915).

Recall Details

Product Type: Devices
Report Date: Apr 6, 2022
Initiation Date: Jan 28, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14220 (US 13305, OUS 915)

Product Description

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).

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.

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.

Code Information

[lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA UDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0830-2022
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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