Z-2201-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- May 20, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 943 systems
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-).
Distribution Pattern
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.
Code Information
List Number: 03R70-01 ALL LOTS