medical Class II Updated 2023-12-27

Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, a

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Affected States: 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, WY
Lot/Code Info: All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.
View official government recall

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