COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. Serial Number: all.
FDA device recall Z-1241-2012 · posted 2012-03-21 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner.
- Action taken
- Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 8,922 units total (4,073 units in US)
- Distribution
- Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulga
- Date initiated
- 2011-12-01
- Date posted
- 2012-03-21
- Date terminated
- 2014-09-02
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER LH 780 HEMATOLOGY ANALYZER (K061616) | Beckman Coulter, Inc. | 2006-10-04 |