Reported Mar 15, 2017 · Terminated

CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated…

Abbott Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories · 4551 Great America Pkwy · Santa Clara, CA · 95054-1208

Is this the product you have?

  • CELL-DYN Ruby SystemList
  • Number08H6701
  • HematologyThe CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
Lot codes and dates
  • Affected serial numbers

    116 of 116 codes

    • 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
  • UPDATE2-28-17 -
  • five additional serial numbers added
    • 55899BG
    • 55900BG
    • 55901BG
    • 55902BG 55904BG
Amount recalled
116

Why it was recalled

The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Abbott Laboratories recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 6, 2018 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.