Abbott Alinity i Processing Module Recalled for Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves FDA Class II classification with unlabeled latex (a common allergen) in a medical device. Following the rubric for allergen mislabeling on common allergens without reported illness, the severity is High.
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
- Affected units
- 1,325
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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