FDA Device recall Z-0173-2020

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01

FDA Device
Class II
terminated
Published 2019-10-30

On 2019-10-30 the FDA classified a Class II recall of Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01 by Abbott Laboratories, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0173-2020
Classification	Class II
Status	terminated
Initiated	2019-05-09
Published	2019-10-30
Last updated	2026-09-13 11:55 UTC
Company	Abbott Laboratories
Distribution	GA, LA, MA, NC, NY, SC, TX

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.

Identifiers

code_info	Tubing lot #2018-10-16; Instrument serial numbers 007689, 007690, 007691, 007692, 007705, 007706, 007707, 007708, 00770… 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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0173-2020%22

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