Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software ...
FDA Device Recall #Z-1653-2025 — Class II — March 18, 2025
Recall Summary
| Recall Number | Z-1653-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 18, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Laboratories |
| Location | Abbott Park, IL |
| Product Type | Devices |
| Quantity | 146 |
Product Description
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
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.
Distribution Pattern
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.
Lot / Code Information
UDI-DI 00380740017170 SNs: 34006BG96 34013BG96 34022BG96 34026BG96 34045BG96 34048BG96 34050BG96 34052BG96 34053BG96 34061BG96 34068BG96 34103BG96 34109BG96 34134BG96 34154BG96 34171BG96 34174BG96 34182BG96 34188BG96 34194BG96 34229BG96 34250BG96 34254BG96 34264BG96 34285BG96 34289BG96 34317BG96 34334BG96 34338BG96 34343BG96 34348BG96 34359BG96 34383BG96 34392BG96 34422BG96 34425BG96 34426BG96 34430BG96 34431BG96 34434BG96 34445BG96 34457BG96 34479BG96 34486BG96 34503BG96 34507BG96 34532BG96 34549BG96 34556BG96 34584BG96 34591BG96 34592BG96 34595BG96 34602BG96 34603BG96 34647BG96 34650GB96 34651BG96 34655BG96 34671BG96 34683BG96 34694BG96 34698BG96 34723BG96 34733BG96 34761BG96 34774BG96 34778BG96 34814BG96 34840BG96 34891BG96 34912BG96 34917BG96 34936BG96 34962BG96 34985BG96 34986BG96 35011BG96 35035BG96 35037BG96 35040BG96 35083BG96 35084BG96 35109BG96 35129BG96 35136BG96 35162BG96 35197BG96 35210BG96 35234BG96 35238BG96 35243BG96 35266BG96 35269BG96 35289BG96 35303BG96 35458BG96 35460BG96 35464BG96 35472BG96 35519BG96 35732BG96 35743BG96 35774BG96 35849BG96 35861BG96 36158BG96 36305BG96 36338BG96 36350BG96 36351BG96 36356BG96 36599BG96 36646BG96 36659BG96 36690BG96 36763BG96 36766BG96 36820BG96 36844BG96 54017BG96 54056BG96 54083BG96 54106BG96 54118BG96 54139BG96 54145BG96 54147BG96 54148BG96 54150BG96 54158BG96 54213BG96 54254BG96 54363BG96 54400BG96 54602BG96 54932BG96 54981BG96 70474BG96 70510BG96 71057BG96 71210BG96 71481BG96 71644BG96 71794BG96 71909BG96
Other Recalls from Abbott Laboratories
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0961-2026 | Class II | Alinity ci-series System Control Module (SCM), ... | Nov 13, 2025 |
| Z-0489-2026 | Class II | Brand Name: Alinity hq Analyzer Product Name: ... | Sep 18, 2025 |
| Z-1652-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-D... | Mar 18, 2025 |
| Z-1655-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-D... | Mar 18, 2025 |
| Z-1656-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-D... | Mar 18, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.