FDA Devices recall · Reported August 14, 2019
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE 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 sam
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
Abbott Gmbh & Co. Kg recalled The Alinity ci-series System Control Modules which are configured with Alinity c Processi… - a moderate-severity action.
The Alinity ci-series System Control Modules which are configured with Alinity c Processi… was recalled by Abbott Gmbh & Co. Kg in August 14, 2019. Reason: All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Techn…. Check the official notice for the remedy. Verify recall #Z-2201-2019 with the FDA Devices before acting.
The recall
Abbott Gmbh & Co. Kg issued this moderate-severity FDA Devices recall-All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Techn….
- Moderate
- severity level
- Class II
- classification
- August 14, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2201-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE 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. The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
Reason for recall
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2201-2019 |
| Date reported | August 14, 2019 |
| Date initiated | May 21, 2019 |
| Recalling firm | Abbott Gmbh & Co. Kg |
| Firm location | Wiesbaden, N/A |
| Affected scope | 943 systems |
| Distribution | Worldwide Distribution - US Nationwide AL, AR, CA,, FL, GA, ID, IL, LA, MA, ME, MI, MN, MO, NJ, NY, OK, SC, TN, TX, UT, VA, WA, WI, and PUERTO RICO. ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM,BOTSWANA, BRAZIL, BU… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2201-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026