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.
Reported: January 17, 2024 Initiated: October 19, 2023 #Z-0680-2024
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).
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 1,325 systems
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: 1,325 systems.
Why was this product recalled? ▼
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0680-2024.
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