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

Recall date

February 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1438-2017

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

US and 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, Luxembourg.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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