—#103461

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.

FDA product code: GGK — Products, Red-Cell Lysing Products
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and 0712002.

Why it was recalled

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 (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-07-11
Posted by FDA: 2011-09-19
Terminated: 2012-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.