Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number

FDA device recall Z-0604-2024 · posted 2023-12-21 · Open, Classified

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GKZ

Quantity affected

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.

Date initiated

2023-10-19

Date posted

2023-12-21

Location

Abbott Park, IL

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