Severity
Moderate
ModerateClass IITerminated
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-).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2201-2019) was formally reported on August 14, 2019, with the manufacturer initiating the action on May 21, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Gmbh & Co. Kg is listed as the recalling firm, operating out of Wiesbaden, N/A. Federal records list the affected scope as 943 systems.
The documented reason for this recall is: 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-). Distribution data in the federal record shows the product reached: 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,…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
943 systems
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Abbott Gmbh & Co. Kg. Units affected: 943 systems.
Why was this product recalled? ▼
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-).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2201-2019.
Where was the recalled product distributed? ▼
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, BULGARIA, CANADA, CHILE, CHINA, COLUMBIA, CROTIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDOESIA, IRELAND, ISRAEL, JORDAN, KENYA, KUWAT, LATVIA, LEBONON, MEXICO, NAMIBA, NETHERLANDS, NORWAY, PACKISTAN, PHILLINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDON, and VIETNAM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2201-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.