Recall Z-2042-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER LH 500 Series Analyzer Part number: 178832, 178833, 178834 The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semiautomated reticulocyte analysis.
| Date | Apr 20, 2011 (initiated Mar 2, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer. |
| Root cause | Other |
| Action | The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated March 2, 2011, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER LH 500 Series Analyzer, COULTER HmX Hematology Analyzer, and COULTER HmX Hematology Analyzer with Autoloader. The letter described the product, problem and actions to be taken. Customers were informed that the suspect Integrated Circuit Chips have been removed from all systems in inventory and manufacturing. The customers were instructed to share this information with their laboratory sta |
| Quantity | 288 units total (158 in US) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032000 | COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Aug 13, 2003 |