Recall Z-2062-2018 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
| Date | Mar 27, 2018 |
| Status | Terminated |
| 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 distri |
| Distribution | Nationwide and worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., Jun 30, 1999 |