Official recall record

Alinity ci-series System Control Module, REF: 03R70-01

What the authority reported

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.

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.

More recalls: US FDA — Medical Devices · United States · all filters

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.

• 2025-11-13 · US FDA — Medical Devices
  Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Other recalls from this brand

• 2025-11-13 · US FDA — Medical Devices
  Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
• 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
• 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

All 6 official recall notices naming Abbott Laboratories on this site →