ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide… recallZ-0011-2014 · Siemens Healthcare Diagnostics · initiated Aug 12, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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 @ [email protected]
Recall details
- Recall number
- Z-0011-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 12, 2013
- Posted by the FDA
- Oct 17, 2013
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 311 units total (US: 51 units; Foreign: 260 units)
- Product code
- GKZ
- FDA submissions
- K102644
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
Other devices under the same FDA submission
2 devices cleared under K102644 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® 2120i Hematology System 10285573Siemens Healthcare Diagnostics Inc. · Counter, differential cell1 recall28 reports
- ADVIA® 2120i Hematology System 10488923Siemens Healthcare Diagnostics Inc. · Counter, differential cell1 recall12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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