FDA: Class I recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate

Editor's Note

The Food and Drug Administration (FDA) on December 9 identified the recall by Remel, Inc, of its Thermo Scientific Gram Negative IVD AST Sensititre Plate as Class I, the most serious.

The Plates are used to test the susceptibility of Gram-negative bacterial infections to specific antibiotics.

The recall was initiated because of the risk for false susceptible results.

Distribution dates were January 26, 2021 to October 16, 2022.

The company has received one complaint, and the FDA has received five reports. There have been no known injuries or deaths.