Z-2352-2010

CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir...

Name: Z-2352-2010 CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir...
Creator: Abbott Laboratories
Published: 2010-04-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-04-16 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802 on 2010-04-16. The reason FDA records is "Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks". 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-2352-2010
Status: Terminated
Initiated: 2010-04-16
Posted: 2010-09-02
Terminated: 2010-12-06
Recalling firm: Abbott Medical
Product: CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
Product code: GKZ Counter, Differential Cell
Reason for recall: Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.
Quantity in commerce: 69 units total
Distribution: Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
Product codes and lots: Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- 08H67-01/35286BG-35318BG, 34891BG, 34641BG, 34408BG, 34890BG, 34021BG

Product code GKZ

K061667Class IICell-Dyn Ruby SystemAbbott Laboratories / cleared 2006-07-10

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)