Abbott Laboratories: 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

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

Details from the source

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. Quantity: 670 devices (329 US and 341 OUS) Lot/code info: All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.

UPC codes

00380740017170, 00380740016616

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.