Alinity ci-series System Control Module, REF: 03R70-01 Recall
Issued January 3, 2024 · Abbott Laboratories
In January 2024, Abbott Laboratories recalled the Alinity ci-series System Control Module, REF: 03R70-01, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Alinity ci-series System Control Module, REF: 03R70-01 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Abbott Laboratories
- Category
- Health
- Recall date
- January 3, 2024
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-0613-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott Laboratories has 31 recalls in our database, including 19 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.