Recall Z-0681-2024— 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 c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).. 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 c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
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.