# FDA recall Z-2201-2019

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2019-05-21.

## Product

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 detecti

## 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-).

## 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.

## Key facts

- **Recall number:** Z-2201-2019
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-08-14
- **Termination date:** 2025-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2019

## Citation

> AI Analytics. FDA recall Z-2201-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2201-2019. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*