FDA recall record · openFDA

Abbott Laboratories

14 FDA recalls on record (2023–2025) — 14 device. 14 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future d 5

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(la 4

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, includin 1

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by corr 1

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following o 1

Recalls

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v Class II 2025-03-18 Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Class II 2025-11-13 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v Class II 2025-03-18 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v Class II 2025-03-18 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5. Class II 2025-09-18 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v Class II 2025-03-18 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v Class II 2025-03-18 Alinity hq Analyzer, REF: 09P68-01 Class II 2024-06-14 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. Class II 2024-02-21 Alinity ci-series System Control Module, REF: 03R70-01 Class II 2023-05-30 Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer Class II 2023-10-19 Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al Class II 2023-10-19 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number Class II 2023-10-19 ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Class II 2023-10-19

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown