FDA Medical Device Recalls (openFDA)
Abbott Laboratories: CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
- Recall number
- Z-2352-2010
- Recalling firm
- Abbott Laboratories
- Product
- CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
- Status
- Terminated
- Initiated
- 2010-04-16
- Posted
- 2010-09-02
- Terminated
- 2010-12-06
- Reason
- Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
- 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
- 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.
- Lot, serial or model codes
- Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- 08H67-01/35286BG-35318BG, 34891BG, 34641BG, 34408BG, 34890BG, 34021BG
- 510(k) numbers
- ["K061667"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28