Lower risk Medical device recall · FDA · Published October 19, 2023

Abbott CELL-DYN Ruby and Sapphire Analyzers May Contain Unlabeled Latex

Abbott recalls two blood analyzers due to unlabeled natural rubber latex in components. Affected models include CD-Ruby and CD Sapphire with specific serial numbers. Consumers should check their devices for latex content.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0604-2024Medical device Abbott ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502

✎ GovInfoNow plain-language explainer

Abbott is recalling two blood analyzers, the CELL-DYN Ruby and Sapphire models, because they contain natural rubber latex that isn't labeled as such. This could cause allergic reactions in sensitive individuals who are allergic to latex. Read more at govinfonow.com/recall/57041-abbott-cell-dyn-ruby-and-sapphire-analyzers-may-contain-unlabeled.

Source Summary by GovInfoNow · govinfonow.com/recall/57041-abbott-cell-dyn-ruby-and-sapphire-analyzers-may-contain-unlabeled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0604-2024

Cite this page

“Abbott CELL-DYN Ruby and Sapphire Analyzers May Contain Unlabeled Latex.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57041-abbott-cell-dyn-ruby-and-sapphire-analyzers-may-contain-unlabeled. Based on FDA recall #Z-0604-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2024%22&limit=1).

The Food and Drug Administration announced on Oct. 19, 2023, that Abbott Laboratories is voluntarily recalling its CELL-DYN Ruby and Sapphire hematology analyzers because they contain unlabeled dry natural rubber (latex) subcomponents. Owners should contact the company for instructions.

How to tell if you have it

Brand: Abbott
Product: CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01
Product: CELL-DYN Sapphire, Model CD Sapphire, List number 08H00-01
Serial numbers: All serial numbers are involved
CELL-DYN Ruby UDI/DI: 00380740017170
CELL-DYN Sapphire UDI/DI: 00380740016616
Quantity: 670 devices (329 US and 341 OUS)

The hazard

The devices contain a dry natural rubber (latex) subcomponent that is not labeled as containing dry natural rubber (latex).

Context

GovInfoNow's records show Abbott Laboratories has issued 33 other recalls since May 14, 2012. Other recent recalls of similar products include Halyard DAVINCI TRUCUSTOM BUNDLE with natural rubber latex labeling issue (July 9, 2026), Stryker NICO BrainPath Shephard's Hook Recall (Oct. 31, 2025), and Stryker NICO Myriad Handpieces Recall (Oct. 31, 2025).

How to tell if you have this one

Check for the model names: CELL-DYN Ruby (CD-Ruby) or CELL-DYN Sapphire (CD Sapphire). The specific serial numbers are listed in the recall notice.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model name on your device: CELL-DYN Ruby (CD-Ruby) or CELL-DYN Sapphire (CD Sapphire).

Where it went and when

Where it was distributed

Distributed in 37 states and Puerto Rico, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 19, 2023Firm started the recall
Dec 21, 2023FDA classified it Class II
Dec 27, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/57041-abbott-cell-dyn-ruby-and-sapphire-analyzers-may-contain-unlabeled">Abbott CELL-DYN Ruby and Sapphire Analyzers May Contain Unlabeled Latex (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0604-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0604-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.