FDA recall Z-0604-2024

Abbott Laboratories · Class II · device

Product

Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

Reason for recall

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

Distribution

Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Brazil.

Key facts

Status
Ongoing
Initiation date
2023-10-19
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2024