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

Lot, batch or date codesUDI-DI 00380740017170 SN: 34036BG96

Quantity recalled1

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-1655-2025
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: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

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 Arkansas Arizona California Colorado Florida Georgia Iowa Illinois Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Dakota Nebraska New Jersey Nevada

Questions about this recall

Is Cell-dyn Ruby recalled?

Yes. Abbott Laboratories recalled Cell-dyn Ruby on 18 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1655-2025.

Why was it recalled?

Which lots are affected?

UDI-DI 00380740017170 SN: 34036BG96

Where was it sold?

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 21 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

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19 Nov 2025Device	CLASS II	Alinity hq Analyzer recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide

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