CLASS II Device recall · Reported 22 Feb 2017 · 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 29 Nov 2016 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-1204-2017
- FDA event ID
- 75942
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2016
- FDA classified
- 15 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Nov 2016 | Recall initiated by company | |
| 15 Feb 2017 | Classified by FDA | +78 days |
| 22 Feb 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
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
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.
Where it was distributed
Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV; and to the country of Canada and others.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth CarolinaNew Hampshire
Questions about this recall
Is CentraLink¿ Data Management System recalled?
Yes. Siemens Healthcare Diagnostics recalled CentraLink¿ Data Management System on 29 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-1204-2017.
Why was it recalled?
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
Which lots are affected?
Product codes: 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841.
Where was it sold?
Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV; and to the country of Canada and others.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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