Recall Z-0604-2024 ยท GKZ Counter, Differential Cell
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.
| Date | Dec 21, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued the Product Correction letter dated 10/19/2023 via FedEx priority overnight express delivery in the U.S. and either in person or mail, telephone, email, or FAX to the OUS consignees. The product correction is for instruments distributed in the U.S. and Brazil only. The letter explains the issue, lists all products involved (some of which have different 806 report numbers and are being submitted by Division III) and that a precautionary label indicating the presence of dry natural rubber (latex) will be applied to the devices by the local Abbott representative. The |
| Quantity | 670 devices (329 US and 341 OUS) |
| 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. |
| FDA record | Open on fda.gov |