cobas e801 Immunoassay Analyzer
Reported: August 17, 2022 Initiated: July 14, 2022 #Z-1515-2022
Product Description
cobas e801 Immunoassay Analyzer
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 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.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
cobas e801 Immunoassay Analyzer. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 965 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2022. Severity: Moderate. Recall number: Z-1515-2022.
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