CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report
Atellica Solution and Atellica Sample Handler Prime recalled
Siemens Healthcare Diagnostics is recalling Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of, distributed in Florida. The recall was initiated on 26 Feb 2018 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-1587-2018
- FDA event ID
- 79683
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2018
- FDA classified
- 1 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Feb 2018 | Recall initiated by company | |
| 1 May 2018 | Classified by FDA | +64 days |
| 9 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Where it was distributed
FL and France Spain Sweden United Kingdom Germany
Questions about this recall
Is Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of recalled?
Yes. Siemens Healthcare Diagnostics recalled Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of on 26 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1587-2018.
Why was it recalled?
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Which lots are affected?
UDI 00630414002439
Where was it sold?
FL and France Spain Sweden United Kingdom Germany
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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