Recall archive / FDA device enforcement

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v... — FDA record Z-1652-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Reason: 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.
Classification: Class II
Recalling firm: Abbott Laboratories
Quantity: 2947
Agency-reported status: Ongoing
Source record identifier: Z-1652-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	UDI-DI 00380740017170 SNs: 30039BG 34021BG 34079BG 34108BG 34123BG 34138BG 34140BG 34149BG 34152BG 34161BG 34177BG 34186BG 34232BG 34242BG 34272BG 34288BG 34302BG 34323BG 34339BG 34349BG 34353BG 34354BG 34364BG 34372BG 34391BG 34395BG 34414BG 34433BG 34439BG 34448BG 34451BG 34458BG 34466BG 34468BG 34473BG 34478BG 34488BG 34491BG 34531BG 34533BG 34539BG 34551BG 34555BG 34559BG 34565BG 34566BG 34598BG 34604BG 34605BG 34620BG 34633BG 34634BG 34646BG 34667BG 34669BG 34695BG 34726BG 34734BG 34736BG 34742BG 34744BG 34758BG 34768BG 34788BG 34789BG 34791BG 34793BG 34805BG 34816BG 34837BG 34839BG 34841BG 34844BG 34850BG 34868BG 34878BG 34881BG 34884BG 34888BG 34893BG 34902BG 34903BG 34907BG 34918BG 34927BG 34933BG 34940BG 34942BG 34950BG 34953BG 34957BG 34965BG 34971BG 34974BG 34975BG 34976BG 34980BG 34984BG 34988BG 34997BG 35016BG 35029BG 35045BG 35049BG 35050BG 35056BG 35061BG 35062BG 35066BG 35067BG 35073BG 35077BG 35089BG 35097BG 35102BG 35104BG 35105BG 35111BG 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Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI 00380740017170 SNs: 30039BG 34021BG 34079BG 34108BG 34123BG 34138BG 34140BG 34149BG 34152BG 34161BG 34177BG 34186BG 34232BG 34242BG 34272BG 34288BG 34302BG 34323BG 34339BG 34349BG 34353BG 34354BG 34364BG 34372BG 34391BG 34395BG 34414BG 34433BG 34439BG 34448BG 34451BG 34458BG 34466BG 34468BG 34473BG 34478BG 34488BG 34491BG 34531BG 34533BG 34539BG 34551BG 34555BG 34559BG 34565BG 34566BG 34598BG 34604BG 34605BG 34620BG 34633BG 34634BG 34646BG 34667BG 34669BG 34695BG 34726BG 34734BG 34736BG 34742BG 34744BG 34758BG 34768BG 34788BG 34789BG 34791BG 34793BG 34805BG 34816BG 34837BG 34839BG 34841BG 34844BG 34850BG 34868BG 34878BG 34881BG 34884BG 34888BG 34893BG 34902BG 34903BG 34907BG 34918BG 34927BG 34933BG 34940BG 34942BG 34950BG 34953BG 34957BG 34965BG 34971BG 34974BG 34975BG 34976BG 34980BG 34984BG 34988BG 34997BG 35016BG 35029BG 35045BG 35049BG 35050BG 35056BG 35061BG 35062BG 35066BG 35067BG 35073BG 35077BG 35089BG 35097BG 35102BG 35104BG 35105BG 35111BG 35112BG 35117BG 35127BG 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70...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 30, 2025
Recall initiation date: Mar 18, 2025
Center classification date: Apr 22, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records