CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Class I - DangerousWhat Should You Do?
- Check if you have this product: Affected serial numbers: 70002BG 70026BG 70050BG 70076BG 70105BG 70141BG 70003BG 70028BG 70051BG 70077BG 70106BG 70142BG 70004BG 70029BG 70052BG 70079BG 70107BG 70144BG 70005BG 70030BG 70054BG 70082BG 70113BG 70146BG 70006BG 70031BG 70056BG 70084BG 70114BG 70147BG 70007BG 70032BG 70058BG 70086BG 70119BG 70149BG 70008BG 70033BG 70059BG 70087BG 70120BG 70164BG 70009BG 70034BG 70061BG 70088BG 70124BG 70165BG 70010BG 70035BG 70063BG 70089BG 70125BG 70166BG 70011BG 70036BG 70064BG 70090BG 70127BG 70167BG 70012BG 70037BG 70065BG 70091BG 70129BG 70170BG 70013BG 70038BG 70067BG 70092BG 70130BG 70171BG 70014BG 70039BG 70068BG 70093BG 70131BG 70178BG 70016BG 70040BG 70069BG 70094BG 70132BG 70181BG 70018BG 70042BG 70070BG 70095BG 70133BG 70183BG 70019BG 70043BG 70071BG 70096BG 70134BG 70189BG 70020BG 70044BG 70072BG 70099BG 70136BG 70021BG 70045BG 70073BG 70100BG 70137BG 70024BG 70046BG 70074BG 70103BG 70138BG 70025BG 70047BG 70075BG 70104BG 70140BG. UPDATE: 2-28-17 - five additional serial numbers added: 55899BG, 55900BG, 55901BG, 55902BG 55904BG.
- 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:
- The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Product Codes/Lot Numbers:
Affected serial numbers: 70002BG 70026BG 70050BG 70076BG 70105BG 70141BG 70003BG 70028BG 70051BG 70077BG 70106BG 70142BG 70004BG 70029BG 70052BG 70079BG 70107BG 70144BG 70005BG 70030BG 70054BG 70082BG 70113BG 70146BG 70006BG 70031BG 70056BG 70084BG 70114BG 70147BG 70007BG 70032BG 70058BG 70086BG 70119BG 70149BG 70008BG 70033BG 70059BG 70087BG 70120BG 70164BG 70009BG 70034BG 70061BG 70088BG 70124BG 70165BG 70010BG 70035BG 70063BG 70089BG 70125BG 70166BG 70011BG 70036BG 70064BG 70090BG 70127BG 70167BG 70012BG 70037BG 70065BG 70091BG 70129BG 70170BG 70013BG 70038BG 70067BG 70092BG 70130BG 70171BG 70014BG 70039BG 70068BG 70093BG 70131BG 70178BG 70016BG 70040BG 70069BG 70094BG 70132BG 70181BG 70018BG 70042BG 70070BG 70095BG 70133BG 70183BG 70019BG 70043BG 70071BG 70096BG 70134BG 70189BG 70020BG 70044BG 70072BG 70099BG 70136BG 70021BG 70045BG 70073BG 70100BG 70137BG 70024BG 70046BG 70074BG 70103BG 70138BG 70025BG 70047BG 70075BG 70104BG 70140BG. UPDATE: 2-28-17 - five additional serial numbers added: 55899BG, 55900BG, 55901BG, 55902BG 55904BG.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1438-2017
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.