ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Reported: June 13, 2018 Initiated: March 27, 2018 #Z-2062-2018
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide and worldwide
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2062-2018.
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