Z-1522-2016Class II

CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is...

Name: Z-1522-2016 CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is...
Creator: Abbott Laboratories
Published: 2016-03-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-03-24 / Terminated

FDA source

Abbott Laboratories began a recall of CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System... on 2016-03-24. FDA classified it as Class II and gives the reason as "Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1522-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Posted: 2016-04-19
Terminated: 2017-01-04
Recalling firm: Abbott Medical
Product: CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
Product code: GKZ Counter, Differential Cell
Reason for recall: Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
FDA root cause: Under Investigation by firm
Action: All customers who were shipped the affected lots were sent a Product Recall letter on March 24, 2016 via Federal Express. Letters were titled Product Recall - Immediate Action Required. An additional four lots were discovered to be affected by the recall and the firm send letters to customers affected by these lots on June 27, 2016
Quantity in commerce: 10,364 plus 9410 additional units for recall expansion.
Distribution: Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.
Product codes and lots: Lot 6853, Expiration date: 31 JUL2017; Lot 6901, Expiration date: 31JUL2017; Lot 6953, Expiration date: 30SEP2017; May 4, 2016 - Firm advised SAN-DO that it has expanded the recall to include three additional lots: Lot 6991, Expiration date: 30NOV2017; Lot 7024, Expiration date: 31DEC2017; Lot: 7027, Expiration date: 31DEC2017. June 28, 2016 - firm added an additional 4 lots to recall: Lot 7044, expiration date 31JAN2018; Lot 7082, expiration date 28FEB2018; Lot 7110, expiration date 31MAR2018; Lot 7119, expiration date 30APR2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)