N Cuvette Segments for BN ProSpec® 10446539Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · The N Cuvette Segments are part of the BN ProSpec system. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 27, 2019Class IITerminated
Iincreased (falsely elevated) Albumin results compared to expected results
Z-2341-2019 · Root cause: Process change control · Recall details · FDA record ↗
Other NEPHELOMETER devices
- BN ProSpec® System 10465217Siemens Healthcare Diagnostics Products GmbH · NEPHELOMETER23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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