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U.S. Department of Health and Human Services

Medical Devices

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StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510

Recall Class: Class I

Date Recall Initiated: January 27, 2010

Product:

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.

Recalling Firm:

StatSpin, Inc., doing business as IRIS Sample Processing
60 Glacier Drive
Westwood, Massachusetts
02090-1800

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

FDA Comments:

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.