ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATI

FDA device recall Z-0011-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.

Action taken

Siemens sent an Urgent Medical Device Correction Letter dated August 8, 2013, and Effectiveness Checks Forms were sent to customers on August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised if they do not have an ADVIA Autoslide connected to their system, no action is required. To avoid the possibility of mislabeling a slide when an ADVIA 2120/2120i rack jam error occurs: Eject the sample rack. Troubleshoot and correct the reason for the rack jam error. Rerun the sample rack. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. If you need additional assistance, please contact Global Product Support Tarrytown, New York @ osggps.hschematology.healthcare@siemens.com

Root cause

Software design

Status

Terminated

Product code

GKZ

Quantity affected

311 units total (US: 51 units; Foreign: 260 units)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines,

Date initiated

2013-08-12

Date posted

2013-10-17

Date terminated

2015-11-18

Location

Tarrytown, NY

Related 510(k) clearances