• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 3 Device Recall see related information
Date Initiated by Firm June 19, 2003
Date Posted August 06, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-1077-03
Recall Event ID 26722
Product Synchron LX Systems Primary Tube Sample Template

(a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems).

Part Number: 967178
Code Information No range of serial numbers apply.
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen M. Jaker
Manufacturer Reason
for Recall
Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
FDA Determined
Cause 2
Action A revised template with a recall letter was sent to customers with a response request on 19 June 2003.
Quantity in Commerce 502
Distribution USA and Canada.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.