Class I Recall for Statspin Express 4 Centrifuges

The U.S. Food and Drug Administration (FDA) just notified healthcare professionals of a Class I recall of the <"">StatSpin Express 4 Centrifuges, Model #510, Serial Numbers 00100 through 001679, which were manufactured and distributed from November 2007 through January 2010.

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.

The recalled Statspin Express 4 Centrifuges rapidly separate blood cells from the liquid portion of blood samples that are collected in special gel collection tubes.

According to the FDA, 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.

According to the prior recall notification issued by the FDA, StatSpin, Inc., also does business as (DBA) IRIS Sample Processing. StatSpin, Inc. is located at 
60 Glacier Drive; Westwood, Massachusetts; 02090-1800. Customers may contact the firm, toll-free, at 1-800-782-8774, Ext. 6123. The original recall notice was issued January 27, 2010.

The FDA noted that on February 3, 2010, the company sent its 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.

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. Details on this program can be accessed at:

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.