FDA-Device2022-08-17Class II
cobas e801 Immunoassay Analyzer
Roche Diagnostics Operations, Inc.
Hazard
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
Sold states
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR.
Affected count
965 units
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
cobas e801 Immunoassay Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1515-2022Don't want to check this manually?
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