Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1030-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA 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 Classification:

Class II

Date Initiated: November 3, 2015

Date Posted: March 9, 2016

Recall Number: Z-1030-2016

Event ID: 73080

Reason for Recall:

Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other markers of renal injury.

Status: Terminated

Product Quantity: 1637 units.

Code Information:

Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign

Distribution Pattern:

Worldwide Distribution and US in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated