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
70002BG70026BG70050BG70076BG70105BG70141BG70003BG70028BG70051BG70077BG70106BG70142BG70004BG70029BG70052BG70079BG70107BG70144BG70005BG70030BG70054BG70082BG70113BG70146BG70006BG70031BG70056BG70084BG70114BG70147BG70007BG70032BG70058BG70086BG70119BG70149BG70008BG70033BG70059BG70087BG70120BG70164BG70009BG70034BG70061BG70088BG70124BG70165BG70010BG70035BG70063BG70089BG70125BG70166BG70011BG70036BG70064BG70090BG70127BG70167BG
- UPDATE2-28-17 -
- five additional serial numbers added
55899BG55900BG55901BG55902BG 55904BG
- Affected serial numbers
- 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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