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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Ruby

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 Class 2 Device Recall CELLDYN Rubysee related information
Date Initiated by FirmMarch 18, 2025
Date PostedApril 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1652-2025
Recall Event ID 96567
510(K)NumberK061667 
Product Classification Counter, differential cell - Product Code GKZ
ProductBrand 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
Code Information 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 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FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd Bldg Ap8b
Abbott Park IL 60064-3502
For Additional Information ContactSuchin Song
1-224-6680343
Manufacturer 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.
FDA Determined
Cause 2		Software change control
ActionOn 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.
Quantity in Commerce2947
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GKZ
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