Abbott Hematology Analyzers Recalled for Unlabeled Latex Component
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Mislabeled latex allergen on medical devices used in healthcare settings, classified as FDA Class II. Latex is a common allergen; no illnesses or hospitalizations are reported. Per the severity rubric, allergen mislabeling on common allergens is categorized as High.
Plain-English summary
Abbott Laboratories is recalling Abbott CELL-DYN Ruby and CELL-DYN Sapphire hematology analyzers due to an unlabeled dry natural rubber (latex) subcomponent.
The recall involves all serial numbers of two models: CELL-DYN Ruby (Model CD-Ruby, List number 08H67-01) and CELL-DYN Sapphire (Model CD Sapphire, List number 08H00-01). A total of 670 devices are affected—329 distributed in the United States across 33 states plus Puerto Rico (including government and military facilities), and 341 distributed internationally, including Brazil.
The unlabeled presence of latex in these medical devices poses a risk to individuals with latex sensitivity who use or interact with the analyzers in healthcare settings. Latex is a known allergen that should be clearly disclosed on medical device labeling. Affected users should discontinue use of these devices immediately and contact Abbott Laboratories for replacement, repair, or return instructions.
The recalled product
- 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.
- Manufacturer
- Abbott Laboratories
- Category
- Medical Device
- Hazard
- allergen-latex
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170
- CELL-DYN Sapphire - UDI/DI 00380740016616.
Distribution
Distributed in 37 states:
- 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
- WY
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