FDA recall Z-0173-2020

Abbott Laboratories · Class II · device

Product

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

Reason for recall

The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.

Distribution

Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.

Key facts

Status
Terminated
Initiation date
2019-05-09
Report date
2019-10-30
Termination date
2020-10-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2020