Product Safety Recalls

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Roche Diagnostics Operations, Inc. Recall 90657

Description: cobas e801 Immunoassay Analyzer

Roche Diagnostics Operations, Inc. Recall 90657 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1515-2022
Event ID90657
Event Descriptioncobas e801 Immunoassay Analyzer
Product TypeDevices
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.
Quantity965 units
Recall ReasonSoftware 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.
Device Classification20220817
Device Code InfoUDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
Center Classification Date20220811
Recall Initiation Date20220714
Recalling FirmRoche Diagnostics Operations, Inc.
Initial Notification Letter
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