Recall Z-1515-2022— Roche Diagnostics Operations, Inc.
Class II · Ongoing
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2022-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas e801 Immunoassay Analyzer. 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
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-14
- Firm location
- Indianapolis, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.