Reported Dec 24, 2025 · Ongoing
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
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 (SCM)
- REF
03R70-0103R70-20
- Lot codes and dates
- UDI-DI00380740137410
- GTIN06952999490048. Software versions 3.6.1 and lower
- Serial NumbersSCM
3,611 of 3,611 codes
SCM01010SCM01012SCM01016SCM01035SCM01043SCM01051SCM01063SCM01069SCM01075SCM01076SCM01078SCM01082SCM01085SCM01086SCM01087SCM01088SCM01092SCM01093SCM01094SCM01095SCM01098SCM01099SCM01101SCM01102SCM01106SCM01107SCM01110SCM01115SCM01116SCM01120SCM01121SCM01122SCM01123SCM01124SCM01126SCM01127SCM01128SCM01129SCM01132SCM01134SCM01135SCM01136SCM01137SCM01138SCM01142SCM01143SCM01149SCM01150SCM01151SCM01154SCM01163SCM01166SCM01170SCM01171SCM01172SCM01174SCM01175SCM01176SCM01179SCM01180
- Amount recalled
- 11653
Where it was sold
Why it was recalled
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
This product could cause temporary or reversible health problems — stop using it.
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