—#213183

Product

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K061667
Affected lot / code info: UDI-DI 00380740017170 SNs: 35939BG 35979BG 36019BG 36103BG 36115BG 36143BG 36171BG 36177BG 36361BG 36788BG 36866BG 54095BG 54431BG 54686BG 54787BG 54900BG 55634BG 55644BG 55656BG 55657BG 55659BG 55662BG 55665BG 55672BG 55673BG 55747BG 55859BG 55879BG 70021BG 70161BG 70204BG 70463BG 70713BG 70931BG 71185BG 71387BG 71388BG 71397BG 71398BG 71476BG 71503BG 71626BG 71637BG 71638BG 71710BG

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.

Root cause (FDA determination)

Software change control

Action the firm took

On March 18, 2025, the firm notified customers through "Urgent Medical Device Correction" letters delivered via FedEx. The letters described the product, problem and actions to be taken. The Customers were instructed to not use expired reagents as this may compromise test accuracy. Always use reagents within their valid expiration dates for all testing procedures. The operator must confirm the container labeling matches the data on the reagent log entry screen dialog box. Quality Controls should be run after any reagent lot number change, maintenance, component replacement, field service action, software change, or calibration. This should be done in accordance with your laboratory s quality control program and regulatory requirements. Complete and return the Customer Reply Form via email: PMS@abbott.com or fax: 1-800-777-0051. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction, provide to them a copy of this letter and retain this letter for your laboratory records. If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502

Distribution

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.

Timeline

Recall initiated: 2025-03-18
Posted by FDA: 2025-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.