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Remel, Inc. Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results
Remel, Inc. is recalling the 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 antibiotics doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
Customers with questions about this recall should contact Thermo Fisher Scientific Microbiology at 800-255-6730 or email microbiology.ts.us@thermofisher.com.
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