Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v
Summary
The FDA issued a Class II for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 by Abbott Laboratories. Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user tha.
Details
Source
Device Recall
External ID
Z-1653-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 146
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-18
Company
Abbott Park, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1653-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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