Recall Z-0397-2017— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0397-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-05

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2016-10-05, terminated 2019-08-29. It names one FDA 510(k) clearance: K110586. Product: Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test). Reason: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Terminated: 2019-08-29
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAYSiemens Healthcare Diagnostics, Inc.·cleared 2011-10-14

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

Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)

Reason for recall

Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples

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