Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. Quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
This recall has been terminated (originally issued March 18, 2011).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- December 14, 2010
- Posted
- March 18, 2011
- Terminated
- September 2, 2014
- Recall Number
- Z-1730-2011
- Quantity
- 4288 units total
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.
Distribution
Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
Lot / Code Info
All serial numbers.
Root Cause
Other
Action Taken
The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical 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 local Beckman Coulter representative.