Z-0604-2024Class II

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

Name: Z-0604-2024 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire...
Creator: Abbott Laboratories
Published: 2023-10-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-10-19 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Laboratories began a recall of 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... on 2023-10-19. FDA classified it as Class II and gives the reason as "The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0604-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-19
Posted: 2023-12-21
Recalling firm: Abbott Medical
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.
Product code: GKZ Counter, Differential Cell
Reason for recall: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0604-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0604-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21

Product code GKZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)