Company: Roche Diagnostics Operations, Inc.
Date of Enforcement Report: 8/11/2022
Class II
PRODUCT
cobas e801 Immunoassay Analyzer
Recall Number:
Z-1515-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc. Voluntary. Firm Initiated.
VOLUME OF PRODUCT IN COMMERCE
965 units
DISTRIBUTION
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.
