Z-2201-2019Class II

The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The...

Name: Z-2201-2019 The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The...
Creator: Abbott Gmbh & Co. KG
Published: 2019-05-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-05-21 / Terminated / root cause: software

FDA source

Abbott Gmbh & Co. KG began a recall of 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,"*... on 2019-05-21. FDA classified it as Class II and gives the reason as "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-)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2201-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-21
Posted: 2019-08-06
Terminated: 2025-05-20
Recalling firm: Abbott Medical
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 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).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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-).
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On May 21, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all of their consignees which advised them of the problem and provided them with instructions for preforming additional testing. US customers were sent this letter and an attached Customer Reply Immediate Action Required form vis FedEx priority overnight express. Abbott service personnel will follow-up to install new software.
Quantity in commerce: 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, 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.
Product codes and lots: List Number: 03R70-01 ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2201-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2201-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)