Roche Diagnostics Operations, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1515-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

cobas e801 Immunoassay Analyzer

Product Classification:

Class II

Date Initiated: July 14, 2022

Date Posted: August 17, 2022

Recall Number: Z-1515-2022

Event ID: 90657

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.

Status: Ongoing

Product Quantity: 965 units

Code Information:

UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated