Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2450-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Product Classification:

Class II

Date Initiated: July 23, 2015

Date Posted: September 2, 2015

Recall Number: Z-2450-2015

Event ID: 71831

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.

Status: Terminated

Product Quantity: Total 1655 units

Code Information:

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

Distribution Pattern:

US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI

Voluntary or Mandated:

Voluntary: Firm initiated