Z-0339-2016Class II

Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative...

Name: Z-0339-2016 Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-09-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-09-30 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma... on 2015-09-30. FDA classified it as Class II and gives the reason as "Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0339-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-30
Posted: 2015-11-25
Terminated: 2016-09-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
Product code: JGJ Photometric Method, Magnesium
Reason for recall: Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers. 1. An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following: Siemens has received customer complaints for Dimension Vista MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results. Discontinue use and discard their remaining inventory of the affected lot. Review the letter with their Medical Director. Siemens will replace any unused inventory of the affected lot.
Quantity in commerce: 3601
Distribution: Distributed US (nationwide) including DC and the states of IL, CA, GA, LA, TX, TN, FL, SC, IA, TN, DE, NJ, WA, MS, KY, NY, WI, OH, OH, MO, UT, KS, VA, AR, WV, MA, PA, AL, CO, IN, MT, NM, ME, AZ, NM, MO, and NC, and the country of Canada.
Product codes and lots: Lot Number 15063BA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0339-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0339-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25

Product code JGJ

K061655Class IIDimension Vista Flex Reagent CartridgesDade Behring, Inc. / cleared 2006-07-10

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)