The New England district office of the Food & Drug Administration issued a Class 1 recall notice for the StatSpin Express 4 Centrifuges, a product that rapidly separates blood cells from plasma, made by IRIS Sample Processing.
The problem is based in a faulty rotor that can break and cause a chain reaction, according to
a recall notice issued Jan. 27.
“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 recall notice.
Westwood, Mass.-based IRIS Sample Processing has sent out a letter to its distributors warning them of the recall, according to the FDA.
Class 1 recalls are the most serious type of recall and involve any situation where there is a reasonable probability that use of the products could result in serious health consequences or death.
According to the company’s website, the StatSpin device is distributed in the U.S. by Thermo Fisher Scientific Inc. (NYSE:TMO), Cardinal Health (NYSE:CAH)and McKesson Medical (NYSE:MCK), among others.