Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent

Plain-English summary

Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems (List Number 03R65-01). The Alinity i Processing Module is a fully automated immunoassay analyzer used in laboratory settings. The devices contain a dry natural rubber (latex) subcomponent that is not identified or labeled as containing latex.

Latex is a known allergen. Individuals with latex sensitivity or allergies may experience allergic reactions through contact with or exposure to the unlabeled latex component. Healthcare workers and laboratory personnel using these devices may be at risk if unaware of the latex presence.

The affected devices have been distributed throughout the United States and Brazil. They are identified by List Number 03R65-01 and can be located using the Serial Numbers and UDI-DI codes specified in the FDA recall notice.

Individuals or facilities using the affected Alinity i Processing Module devices should discontinue use or contact Abbott Laboratories for information about corrective actions. Those with known latex allergies should exercise caution around any recalled units.

The recalled product

Product

Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology.

Manufacturer

Abbott Laboratories

Category

Medical Device — Laboratory Immunoassay Analyzer

Hazard

• allergen-latex
• mis-labeling

Distribution

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