FDA Enforcement
Class I
Terminated
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Recall: Z-0327-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0327-2023
- Event ID
- 91104
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2022
- Initiation Date
- October 20, 2022
- Classification Date
- December 7, 2022
- Termination Date
- September 30, 2024
- Address
- 12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States
Description
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Reason
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.
Code Info
Lot Numbers: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A
Distribution
US Nationwide Distribution
Quantity
1917 units