Recall Z-2256-2016— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2256-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-26

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-05-26, terminated 2018-06-07. It names one FDA 510(k) clearance: K141999. Product: ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.. Reason: Eight (8) issues were identified which may affect the results generated by the system software version..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Terminated: 2018-06-07
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K141999 — ADVIA CENTAUR TSHSiemens Healthcare Diagnostics, Inc.·cleared 2015-04-22

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 XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

Reason for recall

Eight (8) issues were identified which may affect the results generated by the system software version.

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