Recall Z-1653-2025— Abbott Laboratories

Name: FDA recall Z-1653-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-18

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2025-03-18. It names one FDA 510(k) clearance: K061667. Product: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 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..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2025-03-18
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K061667 — CELL-DYN RUBY SYSTEMAbbott Laboratories·cleared 2006-07-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.