Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2062-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

Product Classification:

Class II

Date Initiated: March 27, 2018

Date Posted: June 13, 2018

Recall Number: Z-2062-2018

Event ID: 79932

Reason for Recall:

Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513

Distribution Pattern:

Nationwide and worldwide

Voluntary or Mandated:

Voluntary: Firm initiated