PlainRecalls
FDA Devices Moderate Class II Ongoing

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Reported: March 16, 2022 Initiated: January 10, 2022 #Z-0722-2022

Product Description

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Reason for Recall

There are lower than expected MICs for some gram negative species.

Details

Recalling Firm
Remel Inc
Units Affected
1210 devices
Distribution
Distribution throughout the United States.
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format. Recalled by Remel Inc. Units affected: 1210 devices.
Why was this product recalled?
There are lower than expected MICs for some gram negative species.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0722-2022.