FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
- Recall number
- Z-2062-2018
- 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
- Status
- Terminated
- Initiated
- 2018-03-27
- Posted
- not on file
- Terminated
- 2021-02-03
- Reason
- Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
- 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.
- Quantity
- not on file
- Distribution
- Nationwide and worldwide
- Lot, serial or model codes
- Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
- 510(k) numbers
- ["K991576"]
- PMA numbers
- not on file
- Product code
- CDQ
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28