Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed 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
Recall status
Ongoing — the recall is still being carried out.
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.
Recall record
- Recalling firm
- Abbott Laboratories
- Product type
- Devices
- Recall number
- Z-1653-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Abbott Park, IL
- Recall initiated
- 2025-03-18
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1653-2025 · Source: openFDA enforcement.