FDA-Device2022-12-14Class I
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Remel Inc
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.
Sold states
US Nationwide Distribution
Affected count
665 units
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0330-2023Don't want to check this manually?
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