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Remel Inc Recall 91104

Description: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Remel Inc Recall 91104 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0334-2023
Event ID91104
Event DescriptionThermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity2656 units
Recall ReasonAn 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.
Device Classification20221214
Device Code InfoLot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027
Center Classification Date20221207
Recall Initiation Date20221020
Recalling FirmRemel Inc
Initial Notification Letter
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