cobas e801 Immunoassay Analyzer
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling 965 cobas e801 Immunoassay Analyzer units distributed nationwide due to a software issue that impacts signals and sample test results during Pre-Wash tests. Six assays are affected by this issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. The affected devices have UDI-DI numbers 07613336158456 and 04015630946198, with catalog numbers 08454345001 and 07682913001, and all serial numbers of these units are included in the recall.
The recall covers cobas e801 analyzers distributed across all U.S. states, the District of Columbia, and Puerto Rico. The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 965 units Lot/code info: UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.