Z-0332-2023 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- October 20, 2022
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1647 units
Product Description
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Numbers: B2281, B2151A, B2034, B1453