Abbott Laboratories: Medical Device Recall in 2019 - (Recall #: Z-0173-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 9, 2019

Date Posted: October 30, 2019

Recall Number: Z-0173-2020

Event ID: 83793

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.

Status: Terminated

Product Quantity: 22 analyzers with tubing

Code Information:

Tubing lot #2018-10-16; Instrument serial numbers 007689, 007690, 007691, 007692, 007705, 007706, 007707, 007708, 007709, 007728, 007694, 007695, 007697, 007766, 007767, 007768, 007765, 007710, 007699, 007700, 007701, and 007703.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated