Summary
The FDA issued a Class II for cobas e801 Immunoassay Analyzer by Roche Diagnostics Operations, Inc.. Reason: Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issu.
Details
Source
Device Recall
External ID
Z-1515-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product Description
cobas e801 Immunoassay Analyzer
Lot/Code Info: UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
Quantity Affected: 965 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-14
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Diagnostics Operations, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Diagnostics Operations, Inc. have FDA actions?
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1515-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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