Z-2062-2018Class II

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

Name: Z-2062-2018 ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-03-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems on 2018-03-27. FDA classified it as Class II and gives the reason as "Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails". 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-2062-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-27
Posted: 2018-06-04
Terminated: 2021-02-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Product code: CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Reason for recall: Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Date recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.
Distribution: Nationwide and worldwide
Product codes and lots: Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2062-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2062-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-04

Product code CDQ

K991576Class IIAdditional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. / cleared 1999-06-30

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)