Z-2341-2019Class II

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in...

Name: Z-2341-2019 N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-06-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-06-27 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2019-06-27. FDA classified it as Class II and gives the reason as "Iincreased (falsely elevated) Albumin results compared to expected results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2341-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Posted: 2019-08-22
Terminated: 2020-05-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: JZW Nephelometer
Reason for recall: Iincreased (falsely elevated) Albumin results compared to expected results
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 664 units
Distribution: Nationwide
Product codes and lots: Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2341-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code JZW

K001647Class IBn Prospec SystemDade Behring, Inc. / cleared 2000-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)