Z-1094-2011

Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field...

Name: Z-1094-2011 Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field...
Creator: Abbott Laboratories
Published: 2010-10-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-10-15 / Terminated

FDA source

Abbott Laboratories began a recall of Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901... on 2010-10-15. The reason FDA records is "There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1094-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2011-02-10
Terminated: 2011-06-07
Recalling firm: Abbott Medical
Product: Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.
FDA root cause: Other
Action: The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to [email protected] even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.
Distribution: Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.
Product codes and lots: Serial numbers ending in 0063,0110,0196,0197, 0230,0281,0285,0293, 0319,0329,0332,0358, 0361,0362,0396,0435, 0440,0468,0474,0606, 0642, 0664, 0687, and 0719 through 1331

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)