Recall Z-1655-2014— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1655-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-10

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-04-10, terminated 2016-05-27. It names one FDA 510(k) clearance: K110586. Product: ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.. Reason: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-10
Terminated: 2016-05-27
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

ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

Reason for recall

Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

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