Recall Z-0909-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
| Date | Jul 18, 2017 |
| Status | Terminated |
| Reason | A warning is being added to the cobas 6000 MODULAR Series System - c501 and the cobas 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance. |
| Root cause | Device Design |
| 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 touch |
| Quantity | 3433 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060373 | COBAS 6000 SERIES SYSTEM Roche Diagnostics, Mar 13, 2006 |