Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby
Medical device recall Z-1653-2025. Published in FDA’s Enforcement Report on Apr 30, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 30, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 146 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
146, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,486 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
34 states and territories.
Every one of them
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Dakota
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 18, 2025.
- FDA classified it on Apr 22, 2025.
- FDA’s Enforcement Report published it on Apr 30, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, of Abbott Park, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.