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Terminated

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

FDA Recall Z-0723-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2016-10-21
Date Terminated2018-06-07
Product QuantityUS: 23 systems; Foreign: 141 systems

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.

Firm Action

An Urgent Medical Device Correction Letter HI17-02.A.US (dated October 21, 2016) and Response Form were sent to US Customers via Federal Express. An Urgent Field Safety Notice was sent to customers outside the US on October 21, 2016, (distribution is determined at the country level). The letters instruct customers to contact their local Siemens technical support representative if they obtain multiple results for one Sample ID. It also informs the customer what to do if the ADVIA 560 Hematology System generates any of the six error messages listed in the letter. For further questions, please call (312) 275-7795.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US Distribution to the states of including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of : Angola, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Japan, Kenya, Malaysia, Mexico, Myanmar, Netherlands, Norway, Pakistan, Portugal, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, Uganda, United Kingdom, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111534ABACUS 3CPDiatron U.S., Inc. · 2012-08-02K112755ABACUS 5Diatron U.S., Inc. · 2012-03-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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