FDA recall Z-0722-2022

Product

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Reason for recall

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

Distribution

Distribution throughout the United States.

Key facts

Status

Ongoing

Initiation date

2022-01-10

Report date

2022-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2022