CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Cell-dyn Ruby recalled by Abbott Laboratories
Abbott Laboratories is recalling Cell-dyn Ruby, distributed nationwide in the US. The recall was initiated on 18 Mar 2025 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-1656-2025
- FDA event ID
- 96567
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2025
- FDA classified
- 22 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 18 Mar 2025 | Recall initiated by company | |
| 22 Apr 2025 | Classified by FDA | +35 days |
| 30 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Where it was distributed
Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth DakotaNebraskaNew JerseyNevada
Questions about this recall
Why was it recalled?
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Which lots are affected?
UDI-DI 00380740017170 SNs: 35939BG 35979BG 36019BG 36103BG 36115BG 36143BG 36171BG 36177BG 36361BG 36788BG 36866BG 54095BG 54431BG 54686BG 54787BG 54900BG 55634BG 55644BG 55656BG 55657BG 55659BG 55662BG 55665BG 55672BG 55673BG 55747BG 55859BG 55879BG 70021BG 70161BG 70204BG 70463BG 70713BG 70931BG 71185BG 71387BG 71388BG 71397BG 71398BG 71476BG 71503BG 71626BG 71637BG 71638BG 71710BG
Where was it sold?
Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.
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.
Other products in this recall event
4 other products · FDA event 96567This product is part of a recall event; the main page for the event is Cell-dyn Ruby recalled by Abbott Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide | |
| CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide | |
| CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide | |
| CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
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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| Device | CLASS II | Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Et Control recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | Nationwide |