Z-0604-2024 Class II Ongoing
FDA device recall Z-0604-2024 was initiated by Abbott Laboratories on October 19, 2023 and is designated Class II. Reason for recall: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). The recall status is ongoing. Affected quantity: 670 devices (329 US and 341 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- October 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 670 devices (329 US and 341 OUS)
Product 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 for Recall
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Distribution Pattern
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.
Code Information
All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.