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VITEK 2 GN Test Kit (Biomerieux) – Performance Guarantee (2022)

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

FDANov 9, 2022Nationwide• Biomerieux Inc

ARTISTE, ONCOR, PRIMUS Anesthesia (Siemens) – Treatment Site Error (2022)

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

High

FDANov 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

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VITEK 2 GN Test Kit (Biomerieux) – Performance Guarantee (2022)

ARTISTE, ONCOR, PRIMUS Anesthesia (Siemens) – Treatment Site Error (2022)

VIDAS Salmonella Test (Biomerieux) – Performance Guarantee (2022)

VIDAS Clinical QC Vidas (Biomerieux) – Temperature Deviation (2022)

API 20 E Strips (Biomerieux) – Performance Guarantee (2022)

API NIT1 NIT2 Reagents (Biomerieux) – Performance Guarantee (2022)

API Staph Strips & Media (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Erythromycin (Biomerieux) – Temperature Deviation (2022)

VITEK 2 Reagent AST-GN99 (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Meropenem/Vaborbactam (Biomerieux) – Temperature Deviation (2022)

PPM Lombard CT&TI-TSA Products (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Amoxicillin/Clavulanic (Biomerieux) – Temperature Deviation (2022)

VITEK 2 Reagent GP Test Kit (Biomerieux) – Temperature Deviation (2022)

VITEK 2 AST-GN80 Test Kit (Biomerieux) – Performance Guarantee (2022)

VITEK 2 Reagent AST-GN79 (Biomerieux) – Temperature Deviation (2022)

PPM Industry Combourg LPT Broth (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Rifampicin (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Imipenem (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Ceftolozane/Tazo (Biomerieux) – Temperature Deviation (2022)

Lombard TSA Product (Biomerieux) – Performance Guarantee (2022)