COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526, 6605527 The COULTER HmX Hematology Analyz
FDA device recall Z-2044-2011 · posted 2011-04-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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 staff and retain this notification as part of their laboratory Quality System documentation. If customers have forwarded any of the affected product(s) listed on the PCA letter to another laboratory, please provide a copy of the letter to them. The customers were instructed to complete and return the enclosed Response Form within 10 days so Beckman are assured they have received this important communication and are taking appropriate action. The customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States and Canada or contact their local Beckman Coulter Representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 288 units total (158 in US)
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Canada, France, Germany, Italy, Spain, United Kingdom, and Singapore.
- Date initiated
- 2011-03-02
- Date posted
- 2011-04-20
- Date terminated
- 2012-05-29
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |