CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
CentraLink Data Management System recalled
Siemens Healthcare Diagnostics is recalling CentraLink Data Management System, distributed nationwide in the US. The recall was initiated on 15 May 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2437-2020
- FDA event ID
- 85737
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2020
- FDA classified
- 26 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 15 May 2020 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +42 days |
| 8 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.
Questions about this recall
Why was it recalled?
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
Which lots are affected?
Software versions: CentraLink Data Management System software version 16.0.2 UDI: 00630414220635 CentraLink Data Management System software version 16.0.3 UDI: 00630414237268
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85737| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica Data Manager recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide |
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