Z-0173-2020Class II

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

Name: Z-0173-2020 Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01...
Creator: Abbott Laboratories
Published: 2019-05-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-05-09 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott... on 2019-05-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0173-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-09
Posted: 2019-10-22
Terminated: 2020-10-07
Recalling firm: Abbott Medical
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.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.
Quantity in commerce: 22 analyzers with tubing
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0173-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0173-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-22

Product code GKZ

K081495Class IICell-Dyn Emerald SystemAbbott Laboratories / cleared 2009-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)