FDAFDA · Food and drugs·Recall number Z-0334-2023
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Published December 14, 2022 · Recall initiated: October 20, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- US Nationwide Distribution
- Lot
- Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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