Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure
Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to instrument stoppage without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Laboratories is recalling 116 units of the CELL-DYN Ruby System, a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The recall is due to a defect in the Pump Relay Printed Circuit Board Assembly (PCBA), which may prematurely fail and lead to instrument stoppage.
The affected units were distributed in the US and numerous international locations, including Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania, Vietnam, United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, and Luxembourg. Specific affected serial numbers are listed in the recall documentation, with an update on February 28, 2017, adding five additional serial numbers.
Clinical laboratories should check their inventory for the affected serial numbers and contact Abbott Laboratories for instructions on how to proceed with the recall. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- 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
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 116
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 55900BG
- 55901BG
- 55902BG 55904BG.
Distribution
Distribution scope not specified by the agency.
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