CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
Advia Chemistry Urea Nitrogen Reagent recalled
Siemens Healthcare Diagnostics is recalling Advia Chemistry Urea Nitrogen Reagent (material number 10309051) for use on Advia 1800, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2062-2018
- FDA event ID
- 79932
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2018
- FDA classified
- 4 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Mar 2018 | Recall initiated by company | |
| 4 Jun 2018 | Classified by FDA | +69 days |
| 13 Jun 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Where it was distributed
Nationwide and worldwide
Questions about this recall
Is Advia Chemistry Urea Nitrogen Reagent (material number 10309051) for use on Advia 1800 recalled?
Yes. Siemens Healthcare Diagnostics recalled Advia Chemistry Urea Nitrogen Reagent (material number 10309051) for use on Advia 1800 on 27 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2062-2018.
Why was it recalled?
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Which lots are affected?
Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
Where was it sold?
Nationwide and worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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