StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510
Recall Class: Class I
Date Recall Initiated: January 27, 2010
StatSpin Express 4 Centrifuges, Model #510, Serial Numbers 00100 through 001679
These products were manufactured and distributed from November, 2007 through January, 2010.
Use: This product rapidly separates blood cells from the liquid portion of blood samples that are collected in special gel collection tubes.
StatSpin, Inc., doing business as IRIS Sample Processing
60 Glacier Drive
Reason for Recall: The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor. These pieces may cause serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms.
Public Contact: Customers may contact the company at 1-800-782-8774, Ext. 6123.
FDA District: New England
On February 3, 2010, the company sent their distributors a letter advising them of the recall and defect. When users return the recalled units, an upgrade kit will be installed to upgrade the unit. If users have a trained technical repair person to install the upgrade kit, the company will send an upgrade kit with instructions.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.