Abbott Laboratories: CELL-DYN Hematology Analyzers Recalled for Unlabeled Latex Components

Agency Publication Date: December 21, 2023

Summary

Abbott Laboratories is recalling 670 units of the Abbott CELL-DYN Ruby and CELL-DYN Sapphire hematology analyzers because they contain a dry natural rubber (latex) subcomponent that was not disclosed on the product labeling. These multi-parameter, automated machines are used in medical settings to analyze blood samples. The recall affects 329 units in the United States and 341 units distributed internationally. Consumers and healthcare facilities using these models should be aware of the presence of latex to prevent accidental exposure to individuals with sensitivities.

Risk

The internal components contain dry natural rubber (latex) which is not listed on the device label, posing a risk of serious allergic reactions or anaphylaxis for healthcare workers or patients with latex allergies who may come into contact with the device or its subcomponents.

What You Should Do

Identify your device by checking the model and list numbers: Abbott CELL-DYN Ruby (Model CD-Ruby, List number 08H67-01) or Abbott CELL-DYN Sapphire (Model CD Sapphire, List number 08H00-01).
Verify the UDI/DI information on your equipment: CELL-DYN Ruby carries UDI/DI 00380740017170 and CELL-DYN Sapphire carries UDI/DI 00380740016616. All serial numbers for these models are involved.
Review your facility's safety protocols and identify any personnel or patients with known natural rubber latex allergies who may interact with these specific hematology analyzers.
Contact your healthcare provider or Abbott Laboratories directly at 1-800-527-1869 to discuss any necessary safety precautions, labeling updates, or potential refunds/remedies.
For further information or to report any adverse events, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification regarding latex content

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Abbott CELL-DYN Ruby, Model CD-Ruby

Model / REF:

08H67-01

UDI/DI 00380740017170

Lot Numbers:

All serial numbers involved

Product: Abbott CELL-DYN Sapphire, Model CD Sapphire

Model / REF:

08H00-01

UDI/DI 00380740016616

Lot Numbers:

All serial numbers involved

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93349

Status: Active

Manufacturer: Abbott Laboratories

Sold By: Government distribution; Military distribution

Manufactured In: United States

Units Affected: 670 devices (329 US and 341 OUS)

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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your device by checking the model and list numbers: Abbott CELL-DYN Ruby (Model CD-Ruby, List number 08H67-01) or Abbott CELL-DYN Sapphire (Model CD Sapphire, List number 08H00-01).

Verify the UDI/DI information on your equipment: CELL-DYN Ruby carries UDI/DI 00380740017170 and CELL-DYN Sapphire carries UDI/DI 00380740016616. All serial numbers for these models are involved.

Review your facility's safety protocols and identify any personnel or patients with known natural rubber latex allergies who may interact with these specific hematology analyzers.

Contact your healthcare provider or Abbott Laboratories directly at 1-800-527-1869 to discuss any necessary safety precautions, labeling updates, or potential refunds/remedies.

For further information or to report any adverse events, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.