Z-1655-2025Class II

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All...

Name: Z-1655-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All...
Creator: Abbott Laboratories
Published: 2025-03-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-03-18 / Open, Classified / root cause: software

FDA source

Abbott Laboratories began a recall of Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby... on 2025-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1655-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-18
Posted: 2025-04-22
Recalling firm: Abbott Medical
Product: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: software
FDA root cause: Software change control
Action: 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: [email protected] 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.
Quantity in commerce: 1
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.
Product codes and lots: UDI-DI 00380740017170 SN: 34036BG96

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1655-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1652-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22
Z-1653-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22
Z-1654-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22
Z-1655-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22
Z-1656-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-22

Product code GKZ

K061667Class IICell-Dyn Ruby SystemAbbott Laboratories / cleared 2006-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)