CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
N Cuvette Segments for BN ProSpec System-IVD a system recalled
Siemens Healthcare Diagnostics is recalling N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination, distributed nationwide in the US. The recall was initiated on 27 Jun 2019 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-2341-2019
- FDA event ID
- 83311
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Jun 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +56 days |
| 28 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Iincreased (falsely elevated) Albumin results compared to expected results
Product as listed by the FDA
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Iincreased (falsely elevated) Albumin results compared to expected results
Which lots are affected?
Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Where was it sold?
Nationwide
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 26 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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