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FDAMarch 18, 2025device

Brand 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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

00380740017170

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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