FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0604-2024
·
Reported December 27, 2023
Enforcement
- Recall Number
- Z-0604-2024
- Event ID
- 93349
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Laboratories
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2023
- Initiation Date
- October 19, 2023
- Classification Date
- December 21, 2023
- Address
- 100 Abbott Park Rd Bldg Ap8b, N/A, Abbott Park, IL, 60064-3502, United States
Description
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
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Code Info
All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.
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.
Quantity
670 devices (329 US and 341 OUS)