Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software vers
FDA device recall Z-1655-2025 · posted 2025-04-22 · Open, Classified
Recall details
- Recalling firm
- Abbott Laboratories
- 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.
- Action taken
- 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.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- GKZ
- Quantity affected
- 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
- Date initiated
- 2025-03-18
- Date posted
- 2025-04-22
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |