Abbott Laboratories recalls Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al

Recalled January 17, 2024 · FDA recall Z-0681-2024 · Abbott Laboratories

Hazard

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

Units

1,127 systems

Sold at

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

Description

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

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).

Manufacturer(s)

Abbott Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →