FDA recall Z-0680-2024

Abbott Laboratories · Class II · device

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 for recall

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

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

Key facts

Status
Ongoing
Initiation date
2023-10-19
Report date
2024-01-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2024