Recall Z-0613-2024— Abbott Laboratories
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, initiated 2023-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity ci-series System Control Module, REF: 03R70-01. Reason: 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..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-30
- Firm location
- Irving, TX, United States
Product description
Alinity ci-series System Control Module, REF: 03R70-01
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.