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# Remel Recalls Thermo Scientific Sensititre Plates
- URL: https://www.fdaweb.com/remel-recalls-thermo-scientific-sensititre-plates/
- Published: 2022-12-09T12:00:00.000Z
- Updated: 2026-09-14T18:09:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153365

Remel is recalling (Class 1) Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe (including *Proteus* spp., *Providencia* spp., *Morganella Morganii*) when tested with the following antibiotics: Carbapenem (doripenem, ertapenem, meropenem, imipenem), cefepime, piperacillin/tazobactam, and aztreonam.

The *in vitro* diagnostic is used for clinical susceptibility testing of non-fastidious Gram-negative organisms, comprising enterobacterales, *Pseudomonas aeruginosa*, and other non-enterobacteriaceae, according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/remel-inc-recalls-thermo-scientific-gram-negative-ivd-ast-sensititre-plate-risk-potential-false?ref=fdaweb.com). The test results may indicate that treatment with these antibiotics will stop or slow the growth of Proteae Tribe bacteria when that may not be accurate, it says. “A false susceptibility result could lead patients to receive an ineffective treatment and experience serious injury or health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death,” it adds.

Remel, the U.S. agent and part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective actions to prevent future recurrence, the notice says.