Recall Z-2062-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2062-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-03-27, terminated 2021-02-03. It names one FDA 510(k) clearance: K991576. Product: ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems. Reason: Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-27
Terminated: 2021-02-03
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K991576 — ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.·cleared 1999-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.