Recall Z-0173-2020— Abbott Laboratories

Name: FDA recall Z-0173-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-09

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, initiated 2019-05-09, terminated 2020-10-07. It names one FDA 510(k) clearance: K081495. 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: 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..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Terminated
Initiated: 2019-05-09
Terminated: 2020-10-07
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081495 — CELL-DYN EMERALD SYSTEMAbbott Laboratories·cleared 2009-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.