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Class 2 Device Recall cobas e801 |
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Date Initiated by Firm |
July 14, 2022 |
Create Date |
August 11, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1515-2022 |
Recall Event ID |
90657 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product |
cobas e801 Immunoassay Analyzer |
Code Information |
UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact |
Roche Customer Support 800-428-2336
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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.
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FDA Determined Cause 2 |
Software design |
Action |
The 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 Commerce |
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.
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Total Product Life Cycle |
TPLC Device Report
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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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