CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Abbott Cell-dyn Ruby recalled by Abbott Laboratories
Abbott Laboratories is recalling Abbott Cell-dyn Ruby, distributed in 38 states. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0604-2024
- FDA event ID
- 93349
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Oct 2023
- FDA classified
- 21 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 21 Dec 2023 | Classified by FDA | +63 days |
| 27 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Which lots are affected?
All serial numbers are involved. CELL-DYN Ruby - UDI/DI 00380740017170; CELL-DYN Sapphire - UDI/DI 00380740016616.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Laboratories
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity hq Analyzer recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
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