| | Class 2 Device Recall Alinity ciseries System Control Module
Level Sensor, Bulk Solution
Accessory kits, Alinity i and c |  |
| Date Initiated by Firm | March 07, 2019 |
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| Create Date | May 13, 2019 |
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| Recall Status1 |
Terminated 3 on February 19, 2025 |
| Recall Number | Z-1316-2019 |
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| Recall Event ID |
82475 |
| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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| Product | 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). |
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| 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 |
| FEI Number |
3002809144
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Recalling Firm/
Manufacturer |
Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
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| For Additional Information Contact | Albert Chianello
877-422-2688 |
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Manufacturer Reason
for Recall | Potential performance issues in the Alinity-ci software version 2.5.1 |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On March 7, 2019 Abbott issued the attached Product Correction letters to all installed Alinity ci series instrument customers:
1. Softwarerelated actions: Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 2.6.0 to resolve each of these issues. Refer to Appendix A for necessary actions required until software version 2.6.0 can be installed. Software version 2.6.0 also provides enhancements and additional changes to increase the usability of your system. If you require additional information, please contact Abbott
Customer Service.
2. The Alinity ciseries Operations Manual distributed with software version 2.6.0 requires supplemental instructions for the following message:
Message code 3696 The sample probe is not washed after aspirating a whole blood or red blood cell sample. If message code 3696 occurs, perform the following:
a. Perform Asneeded Maintenance procedure 5906 Clean Sample and Reagent Probes (cseries) to clean the sample probe unless one of the following actions occurred before the initiation of assay processing:
" The sample probe was replaced.
" Daily maintenance procedure 5501 Daily Maintenance (cseries) was
performed.
b. Additional messages that are associated with this message can be used to
determine the appropriate corrective action. Perform View additional messages
that are associated with a message in the Alinity ciseries Operations Manual.
3. Bulk Solution Level Sensor related actions (refer to Appendix B for additional
information):
a. If LN 04S6801 Level Sensor, Bulk Solution is installed in the Alinity i Trigger or PreTrigger bulk solution reservoirs, Abbott recommends these sensors be
replaced with a Level Sensor, Bulk Solution, LN 04S6802 before further test
processing is performed.
b. Abbott recommends all LN 04S6801 Level Sensor, Bulk Solution installed in the following bulk solution reservoirs be replaced with a Level Sensor, Bulk Solution, LN 04 |
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| Quantity in Commerce | 1557 |
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| Distribution | 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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