—#204057

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215, K061667
Affected lot / code info: All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 Impact to User Safety is provided and actions to be taken by the customer, which included: Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the listed Abbott products; complete and return the Customer Reply Form; if the consignee has forwarded the product(s) listed to other laboratories, inform them of this Product Correction and provide a copy of the letter; and retain this letter for their laboratory records.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502

Distribution

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.

Timeline

Recall initiated: 2023-10-19
Posted by FDA: 2023-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204057. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.