Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Reported: December 14, 2022 Initiated: October 20, 2022 #Z-0331-2023
Product Description
Thermo SCIENTIFIC, Sensititre CMC5VGNF, 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
- 588 units
- Distribution
- US Nationwide Distribution
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST. Recalled by Remel Inc. Units affected: 588 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-0331-2023.
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