Official recall record
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-11-13
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00380740137410
- Brand on record
- Abbott Laboratories
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-05-30 · US FDA — Medical Devices
Alinity ci-series System Control Module, REF: 03R70-01
Other recalls from this brand
- 2025-03-18 · US FDA — Medical Devices
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All - 2025-03-18 · US FDA — Medical Devices
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All - 2025-03-18 · US FDA — Medical Devices
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All