Data Foundry

Medical device recalls 2019

Emerald Diluent Tubing — Class II medical device recall Z-0173-2020

Terminated recall by Abbott Laboratories, reported 2019-10-30, distributed in GA, LA, MA, NC, NY, SC, TX. The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfa

Recall numberZ-0173-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAbbott Laboratories, Santa Clara, CA, United States
Recall initiated2019-05-09
Classified2019-10-22
Reported by FDA2019-10-30
Terminated2020-10-07
DistributedGA, LA, MA, NC, NY, SC, TX
Countries outside the USAU, DE, GR, HN, ID, IT, RS
Quantity22 analyzers
Serial numbers007689, 007690, 007691, 007692, 007694, 007695, 007697, 007699, 007700, 007701, 007703, 007705, 007706, 007707, 007708, 007709, 007710, 007728, 007765, 007766, 007767, 007768

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0173-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.