N Cuvette Segments for BN ProSpec System-IVD a system for… recallZ-2341-2019 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 27, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Iincreased (falsely elevated) Albumin results compared to expected results
FDA root cause category: Process change control
What the company is doing
Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-19-002.A.US to the US customers June 27, 2019 and May 2019 via FedEx overnight delivery and email to regional countries for implementation Outside the US (OUS). Customers were instructed to contact their Siemens Healthineers Customer Care Center for further follow-up in case they experienced sporadically increased Albumin results compared to expected results. Customers were also instructed to complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Recall details
- Recall number
- Z-2341-2019
- Status
- Terminated
- Initiated by the company
- Jun 27, 2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 664 units
- Product code
- JZW
- FDA submissions
- K001647
- Distribution
- Nationwide
Product description
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
Code information (models, lots, serial numbers)
Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N Cuvette Segments for BN ProSpec® 10446539Siemens Healthcare Diagnostics Products GmbH · NEPHELOMETER1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K001647 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BN ProSpec® System 10465217Siemens Healthcare Diagnostics Products GmbH · NEPHELOMETER23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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