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U.S. Department of Health and Human Services

Class 2 Device Recall cobas e801

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 Class 2 Device Recall cobas e801see related information
Date Initiated by FirmJuly 14, 2022
Create DateAugust 11, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1515-2022
Recall Event ID 90657
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Productcobas e801 Immunoassay Analyzer
Code Information UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Customer Support
800-428-2336
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe firm distributed an Urgent Medical Device Correction notification via mail by UPS on 07/14/2022. The notice indicates that cobas e801 (Catalog No. 08454345001) and cobas e801 module (Catalog No. 04682913001) are being recalled due to a software issue affecting all analyzers, which may result in impacted signals and sample results of Pre-Wash tests when using Quick Start Mode for the following assays: Anti-HAV 2, Anti-HBc IgM, IGF-1, Myoglobin, Rubella IgG, and Toxo IgG. Customers with affected units are provided workaround instructions to deactivate Quick Start Mode or additional software maintenance with Quick Start Mode still activated. The firm states that the issue will be fixed in the next software version release. Customers are asked to return the attached Faxback form. Any questions are to be directed to Roche Customer Service at 1-800-428-2336.
Quantity in Commerce965 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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