Abbott Gmbh & Co. KG: 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).

Recall number

Z-2201-2019

Recalling firm

Abbott Gmbh & Co. KG

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).

Status

Terminated

Initiated

2019-05-21

Posted

not on file

Terminated

2025-05-20

Reason

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

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

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.

Lot, serial or model codes

List Number: 03R70-01 ALL LOTS

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJE

Firm FEI

3002809144

Firm city

Wiesbaden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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