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Remel Inc recalls Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Recalled December 14, 2022 · FDA recall Z-0331-2023 · Remel
Hazard
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. · FDA Class I
Units
588 units
Sold at
US Nationwide Distribution
Description
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Product
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Manufacturer(s)
Remel Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →