ARCHITECT c4000 Processing Module recalled for unlabeled latex component
Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.
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: FDA Class II recall involving allergen mislabeling of latex, a common allergen. No illnesses or injuries reported. Hazard is potential allergic reaction in susceptible individuals.
Plain-English summary
The ARCHITECT c4000 Processing Module, manufactured by Abbott Laboratories, is an automated laboratory analyzer designed to perform chemistry tests using photometry and potentiometric technology. Approximately 995 systems have been distributed across the United States and Brazil.
The devices contain a dry natural rubber (latex) subcomponent that is not labeled as containing latex. This defect poses a potential risk to healthcare personnel with latex allergies who may be exposed during device operation or maintenance.
The recalled systems were distributed to healthcare facilities across multiple U.S. states and in Brazil. Healthcare facilities can identify affected devices by serial number and UDI code, available in the official FDA recall notice Z-0682-2024.
The recalled product
- Product
- ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
- Manufacturer
- Abbott Laboratories
- Affected units
- 995
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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