Recall Z-1730-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
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.
| Date | Mar 18, 2011 (initiated Dec 14, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 identifier |
| Quantity | 4288 units total |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010765 | COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 Beckman Coulter, Inc., Apr 13, 2001 |