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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA 2120/2120i Hematology Systems

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 Class 2 Device Recall ADVIA 2120/2120i Hematology Systemssee related information
Date Initiated by FirmAugust 12, 2013
Date PostedOctober 17, 2013
Recall Status1 Terminated 3 on November 18, 2015
Recall NumberZ-0011-2014
Recall Event ID 65898
510(K)NumberK102644 
Product Classification Counter, differential cell - Product Code GKZ
ProductADVIA 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.
Code Information All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactElizabeth Bernasconi
914-524-2495
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionSiemens 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
Quantity in Commerce311 units total (US: 51 units; Foreign: 260 units)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GKZ
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