Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
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…
Read the official notice →- Date
- 2022-08-17
- Country
- United States
- Brand
- Roche Diagnostics Operations
- Product
- cobas e801 Immunoassay Analyzer
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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