Reported Jan 3, 2024 · Ongoing
Alinity ci-series System Control Module, REF: 03R70-01
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 1915 Hurd Dr · Irving, TX · 75038-4313
Is this the product you have?
- Alinity ci-series System Control Module
- REF03R70-01
- Lot codes and dates
- UDI-DI00380740137410. Software Version 3.4.0 and lower
- Amount recalled
- 8,424
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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