StatSpin Express Centrifuge Recall: Risk of Injury, Blood Exposure
A Class 1 recall has been issued for the StatSpin Express 4 Centrifuge, which FDA officials say can malfunction and send parts of the rotor and potentially contaminated blood flying out of the device.
The FDA alerted health care officials to the StatSpin centrifuge recall last week after StatSpin, Inc., the manufacturer, sent a letter to its distributors warning them of the defective centrifuges.
According to the FDA recall notice, the rotor of the centrifuge can break and separate from the motor, damaging a safety switch meant to shut the centrifuge down in case of a problem. The rotor pieces can explode out of the centrifuge housing, which could threaten bystanders with small shrapnel and potentially tainted blood from shattered blood vials in the centrifuge.
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The recall is a Class 1 medical device recall, which means that the FDA has concluded that the defective device has a reasonable possibility of causing serious injury or death.
The recall affects the StatSpin Express 4 Centrifuges, model #510, with serial numbers of 00100 through 001679. The centrifuges were distributed from November 2007 through January 2010 by StatSpin, Incl, doing business ass IRIS Sample Processing.
The company itself first issued the recall on January 27, and then sent a letter to its distributors in early February. The FDA sent out the letter to healthcare professionals alerting them to the recall last week. There have been no reported injuries or deaths related to the defective centrifuges, which are used to spin blood to separate the blood from plasma.
Anyone using the centrifuges should contact the company at 1(800)782-8774, Users can return the devices to have an upgrade kit installed or have an upgrade kit sent to them to be installed by a trained technician.
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