Recall Z-0723-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0723-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-10-21, terminated 2018-06-07. It names 2 FDA 510(k) clearances: K111534, K112755. Product: ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.. Reason: Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-21
Terminated: 2018-06-07
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

2 on FDA's record

K111534 — ABACUS 3CPDiatron U.S., Inc.·cleared 2012-08-02
K112755 — ABACUS 5Diatron U.S., Inc.·cleared 2012-03-27

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 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

Reason for recall

Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.

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