Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Reported: December 14, 2022 Initiated: October 20, 2022 #Z-0328-2023
Product Description
Thermo SCIENTIFIC, Sensititre GN6F, 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.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 2471 units
- Distribution
- US Nationwide Distribution
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST. Recalled by Remel Inc. Units affected: 2471 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2022. Severity: Critical. Recall number: Z-0328-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11