Z-1668-2011

Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and...

Name: Z-1668-2011 Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and...
Creator: Abbott Laboratories
Published: 2010-09-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-09-30 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories began a recall of Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa... on 2010-09-30. The reason FDA records is "The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1668-2011
Status: Terminated
Initiated: 2010-09-30
Posted: 2011-03-17
Terminated: 2011-04-07
Recalling firm: Abbott Medical
Product: Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara. CA Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.
Quantity in commerce: 322 units
Distribution: Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
Product codes and lots: Lot Number: 4350, Expiration Date: June 30, 2012

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)