FDA Device Recall Z-0011-2014: Siemens Healthcare Diagnostics

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-2014.

Recall Res Number

Z-0011-2014

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics

FEI Number

2432235

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-08-12

Date Posted

2013-10-17

Date Terminated

2015-11-18

Product Code

GKZ

Event Number

65898

Product Quantity

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

Product Description ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

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 Details 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

Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.

Code Information / Serial Numbers All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.

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SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration

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Medical Device Recall: Z-0011-2014

Recall Parameters & Description

Related Establishments / Registrations

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