FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.
- Recall number
- Z-3263-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.
- Status
- Terminated
- Initiated
- 2011-07-11
- Posted
- 2011-09-19
- Terminated
- 2012-06-04
- Reason
- The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.
- Root cause
- Pending
- Action
- The recall communication was initiated on 08/01/2011 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US customers) to all customers, who purchased Coulter DxH Cell Lyse. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact Beckman Coulter for product replacement. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their Beckman Coulter representative.
- Quantity
- 4913 units total (2245 in US)
- Distribution
- Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
- Lot, serial or model codes
- Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and 0712002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GGK
- Firm FEI
- 2050012
- Firm city
- Brea
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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