Z-2450-2015Class II

Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC)

Name: Z-2450-2015 Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-07-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-23 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative... on 2015-07-23. FDA classified it as Class II and gives the reason as "customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed...". 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-2450-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Posted: 2015-08-22
Terminated: 2017-03-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Product code: JZG System, Test, Beta-2-Microglobulin Immunological
Reason for recall: customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative.
Quantity in commerce: Total 1655 units
Distribution: US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
Product codes and lots: Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13; Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2450-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2450-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code JZG

K083463Class IIDimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control MSiemens Healthcare Diagnostics / cleared 2009-03-13

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)