Z-0327-2023 Class I Terminated
FDA device recall Z-0327-2023 was initiated by Remel Inc on October 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., Provid… The recall status is terminated (terminated September 30, 2024). Affected quantity: 1917 units.
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
- 1917 units
Product Description
Thermo SCIENTIFIC Sensititre Plate, GN4F, 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: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A