ADVIA Chemistry Urea Nitrogen Reagent recall
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Why was ADVIA Chemistry Urea Nitrogen Reagent recalled?
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
- Product
- ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Distribution
- Nationwide and worldwide
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)