Recall Z-0961-2026— Abbott Laboratories
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, initiated 2025-11-13. It names 2 FDA 510(k) clearances: K170317, K170316. Product: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20. Reason: 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..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-13
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i System
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.