Recall Z-1515-2022
Roche Diagnostics Operations, Inc. · initiated July 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
cobas e801 Immunoassay Analyzer
Codes / lots: UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
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: Software design
Action taken
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.
Details
- Recall number
- Z-1515-2022
- Initiated
- July 14, 2022
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 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.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN