Recall Z-1243-2012 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834; LH 500 Series System Remanufactured (115V), PN A91062; LH 500 Series System Remanufactured (220V), PN A90994 SW Version 2A4, 2A5. Serial Number: all. The COULTER LH 500 Analyzer is a qua
| Date | Mar 21, 2012 (initiated Dec 1, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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 Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiop |
| 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 |