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Terminated

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

FDA Recall Z-0675-2018 · Posted None

Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeJJE
Date Initiated2017-07-28
Date Terminated2020-06-10
Product Quantity399

Reason for Recall

A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.

Firm Action

Consignees were notified by letter (receipt required) and requested to follow instructions to determine if the software issue has occurred. If the software issue is detected the consignee contacts customer support to have system reconfigured.

Root Cause

Device Design

Distribution Pattern

Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp. · 2010-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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