FDA recall Z-0910-2018

Product

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

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.

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.

Key facts

Status

Terminated

Initiation date

2017-07-18

Report date

2018-03-14

Termination date

2018-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0910-2018