Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00380740017170 SNs: 35939BG 35979BG 36019BG 36103BG 36115BG 36143BG 36171BG 36177BG 36361BG 36788BG 36866BG 54095BG 54431BG 54686BG 54787BG 54900BG 55634BG 55644BG 55656BG 55657BG 55659BG 55662BG 55665BG 55672BG 55673BG 55747BG 55859BG 55879BG 70021BG 70161BG 70204BG 70463BG 70713BG 70931BG 71185BG 71387BG 71388BG 71397BG 71398BG 71476BG 71503BG 71626BG 71637BG 71638BG 71710BG
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Product Codes/Lot Numbers:
UDI-DI 00380740017170 SNs: 35939BG 35979BG 36019BG 36103BG 36115BG 36143BG 36171BG 36177BG 36361BG 36788BG 36866BG 54095BG 54431BG 54686BG 54787BG 54900BG 55634BG 55644BG 55656BG 55657BG 55659BG 55662BG 55665BG 55672BG 55673BG 55747BG 55859BG 55879BG 70021BG 70161BG 70204BG 70463BG 70713BG 70931BG 71185BG 71387BG 71388BG 71397BG 71398BG 71476BG 71503BG 71626BG 71637BG 71638BG 71710BG
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1656-2025
Related Recalls
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
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
Abbott Laboratories
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.
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Abbott Laboratories
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.