Recall Z-0680-2024— Abbott Laboratories
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, initiated 2023-10-19. FDA's recall record names no specific 510(k) clearance for this event. 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. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.. Reason: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex)..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-19
- Firm location
- Irving, TX, United States
Product description
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. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Reason for recall
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Data sourced from openFDA. This site is unofficial and independent of the FDA.