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Recall Observatory FDA recall evidence

Device product

Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

Z-0333-2023

October 20, 2022

Class I

Product summary

Firm
Remel Inc
Event
Event 91104
Status
Terminated
Classification
Class I
Quantity
70 units
Official record key
device-enforcement:Z-0333-2023

Official wording

Reason: 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.

Code information: Lot Numbers: B2311B

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.