—#151791

Product

CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Product codes: 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841.

Why it was recalled

There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Healthcare Diagnostics, sent an Urgent Medical Device Correction Notice dated November 29, 2016, to all affected customers within the USA, and and issued notices titled "Urgent Field Safety Notices" to their international customers. Effectiveness Check Forms were also sent to the affected customers. Siemens recommends the LIS specify the sample type in the work order. The CentraLink system is designed to operate in an environment in which the sample type is specified in the work order that is downloaded from the LIS. A Siemens Technical Support Representative will contact affected customers to review your CentraLink configuration. If your LIS does not include sample type information in the sample orders downloaded to CentraLink and Pre-Tests assigned by sample type are configured on the ADVIA Automation System your representative will update your configuration. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (914) 631-8000.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV; and to the country of Canada and others.

Timeline

Recall initiated: 2016-11-29
Terminated: 2018-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151791. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.