CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Alinity ci -series System Control¿Module recalled
Abbott Gmbh & Co. KG is recalling Alinity ci -series System Control¿Module, distributed nationwide in the US. The recall was initiated on 10 Jun 2019 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-2363-2019
- FDA event ID
- 83235
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2019
- FDA classified
- 23 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Jun 2019 | Recall initiated by company | |
| 23 Aug 2019 | Classified by FDA | +74 days |
| 4 Sep 2019 | 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
Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.
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
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.
Which lots are affected?
All serial numbers
Where was it sold?
Worldwide Distribution - US Nationwide
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.
More recalls from Abbott Gmbh & Co. KG
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity ci series System Control Module (SCM) recalled | Abbott Gmbh & Co. KG | Device Malfunction | Nationwide |
| Device | CLASS II | Alinity C, Processing Module recalled by Abbott Gmbh & Co. KG | Abbott Gmbh & Co. KG | Potency & Assay | 25 states |
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