Product Safety Recalls

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Remel Inc Recall 91104

Description: Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

Remel Inc Recall 91104 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0330-2023
Event ID91104
Event DescriptionThermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity665 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: B2206A, B2035A, B1333, B1144A, B0483
Center Classification Date20221207
Recall Initiation Date20221020
Recalling FirmRemel Inc
Initial Notification Letter
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