Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the follow...
FDA Device Recall #Z-1316-2019 — Class II — March 7, 2019
Recall Summary
| Recall Number | Z-1316-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 7, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Gmbh & Co. KG |
| Location | Wiesbaden |
| Product Type | Devices |
| Quantity | 1557 |
Product Description
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) 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
Potential performance issues in the Alinity-ci software version 2.5.1
Distribution Pattern
AR, AZ, CA, FL, GA, IL, MA, ME, MN, MO, NY, OK, SC, TN, TX, UT, VA, WI, and Puerto Rico ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, and VIETNAM.
Lot / Code Information
Alinity ci series System Control Module; LN 3R70 01 Level Sensor, Bulk Solution; LN 04S68 01 Accessory kit, Alinity i; LN 03R66 01, LN 03R66 02 Accessory kit, Alinity c; LN 03R69 01, LN03R69 02
Other Recalls from Abbott Gmbh & Co. KG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2701-2020 | Class II | Alinity ci series System Control Module (SCM); ... | Jun 19, 2020 |
| Z-2401-2020 | Class II | Alinity C, Processing Module. Chemistry analyz... | May 12, 2020 |
| Z-2117-2020 | Class II | ARCHITECT iGentamicin Reagent Kit - Product Usa... | Apr 24, 2020 |
| Z-1728-2020 | Class II | ARCHITECT HAVAB G Reagent Kit. List Number 6L27... | Mar 9, 2020 |
| Z-1580-2020 | Class II | LN 3R70-01; software version 2.6.2 and earlier.... | Jan 24, 2020 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.