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FDA warns that certain StatSpin centrifuges could threaten healthcare workers
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March 3, 2010
The FDA has alerted hospitals that a specific model of StatSpin centrifuges has an alleged defect that could result in injuries.
The centrifuges have been recalled by StatSpin, Inc., of Westwood, MA, which does business under the name Iris Sample Processing.
According to the FDA and manufacturer, the rotor of the centrifuge could break off, strike the lid of the device’s housing, and possibly eject out. “These pieces may cause serious physical injury to bystanders and may expose them to bloodborne infectious microorganisms,” the FDA said in its alert on February 26.
The affected centrifuges are StatSpin Express 4, Model #510, serial numbers 00100 through 001679. They were manufactured and distributed from November 2007 through January 2010.
StatSpin’s Web page doesn’t mention the recall. The FDA said the company issued a letter to distributors on February 3 about the centrifuge problems.
The FDA has qualified this safety recall as Class I, which is the most serious type of recall and involves situations with the risk of serious injuries or death.
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