Alinity recallZ-0613-2024 · Abbott Laboratories · initiated May 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
FDA root cause category: Software design
What the company is doing
On 5/30/23, correction notices were mailed to customers: -If code 5819 occurs, remove cartridges and onboard vial rack. Discard all cartridges and all samples in the onboard vial racks impacted by this issue. If a cartridge or onboard vial rack has fallen over inside the reagent carousel, contact Customer Service to clean any potential spill. -Avoid printing the Sample Laboratory report from the Sample Status Screen. If the Sample Laboratory report is printed verify the correct SID is printed on all pages. -When the barcode on the calibrator carton is scanned, only the master lot number and the expiration date are updated. The calibrator values remain from the previously configured master lot. To configure a new master lot for calibrators that have lot-specific calibrator values, the supervisor must verify that the correct values are entered and must edit them if necessary, or the supervisor must configure the master lot by importing the calibrator data. - Do not create a user defined assay with more than 40 Cuvette SmartWashes or 40 total reagent probe R1 and R2 SmartWashes. NOTE: The All setting can be used to replace individual reagent probe R1 or reagent probe R2 SmartWashes. Reagent probe settings that use the All setting need to be configured last. -Confirm for each user-defined assay that the sum of the configured sample volume + diluent volume + water volume is both greater than or equal to 80 micro L and less than or equal to 360 micro L -The label stock must meet the guidelines in 1D reagent barcode label requirements (c-series) in Section 4 of the Alinity ci-series Operations Manual and be compatible with Avery label templates 5520, L4773, or L7060. -If the ICT module status is exceeded with more than 20,000 samples processed, then confirm the expiration date of the ICT module before performing ICT assay testing. Complete and return the response form Questions can be directed to Customer Service at 1-877-4ABBOTT
Recall details
- Recall number
- Z-0613-2024
- Status
- Open, Classified
- Initiated by the company
- May 30, 2023
- Posted by the FDA
- Dec 22, 2023
- Recalling firm
- Abbott Laboratories
- Quantity
- 8,424
- Product code
- JJE
- Distribution
- US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, , GAZA & JERICHO,GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LITHUANIA, MACEDONIA, MADAGASCAR, MALAYSIA, MALDIVES, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, VIETNAM, ZAMBIA
Product description
Alinity ci-series System Control Module, REF: 03R70-01
Code information (models, lots, serial numbers)
UDI-DI: 00380740137410. Software Version 3.4.0 and lower.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity 03R7001Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE2 recalls498 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page