cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Recall Z-0910-2018 · Posted None
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Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeJJE
Date Initiated2017-07-18
Date Terminated2018-07-13
Product Quantity245
Reason for Recall
A warning is being added to the cobas 6000 analyzer and the cobas 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
Firm Action
Actions Taken by Roche Diagnostics: A warning will be added to the cobas 6000 analyzer series Operators Manual and the cobas 8000 modular analyzer series Operators Manual. Actions to be Taken by the Operator: Operators are advised not to overtighten the thumb screws when replacing the USM Cover 3 after maintenance. When removing the screws for maintenance, avoid touching the edge of the USM Cover 3. Enclosure: Fax back form 7727-00-0717
Actions Required: " Do not overtighten the thumb screws when replacing the USM Cover 3 after maintenance. When removing the screws for maintenance, avoid touching the edge of the USM Cover 3. " Complete the attached fax form and fax it to 1-888-276-5901. " File or post this Urgent Medical Device Correction (UMDC) in an appropriate location within your laboratory, for future reference.
Root Cause
Device Design
Distribution Pattern
Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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