Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall StatSpin Express 4 Centrifuge

  • 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 1 Device Recall StatSpin Express 4 Centrifuge see related information
Date Initiated by Firm January 27, 2010
Date Posted March 04, 2010
Recall Status1 Terminated 3 on November 13, 2019
Recall Number Z-0807-2010
Recall Event ID 54365
Product Classification Centrifuges For Clinical Use - Product Code JQC
Product StatSpin Express 4 Horizontal Centrifuge
Model # M510.

Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
Code Information Serial Numbers: 00100 through 001679.
Recalling Firm/
Manufacturer		 StatSpin, Inc., dba Iris Sample Processing
60 Glacier Dr
Westwood MA 02090-1800
For Additional Information Contact SAME
781-551-0100
Manufacturer Reason
for Recall		 Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
FDA Determined
Cause 2		 Device Design
Action Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.
Quantity in Commerce 1510 units
Distribution Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.
Total Product Life Cycle TPLC Device Report
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.
-
-