Z-0335-2023 Class I Terminated
FDA device recall Z-0335-2023 was initiated by Remel Inc on Oct 20, 2022 and is designated Class I. 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… The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2022
- Initiation Date
- Oct 20, 2022
- Termination Date
- Sep 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Thermo SCIENTIFIC, Sensititre STP7F, 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: B2265A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0335-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026