Recall Z-2341-2019— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2341-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-06-27, terminated 2020-05-27. It names one FDA 510(k) clearance: K001647. 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. Reason: Iincreased (falsely elevated) Albumin results compared to expected results.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Terminated: 2020-05-27
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K001647 — BN PROSPEC SYSTEMDade Behring, Inc.·cleared 2000-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

Iincreased (falsely elevated) Albumin results compared to expected results

Data sourced from openFDA. This site is unofficial and independent of the FDA.