QIAstat-Dx Gastrointestinal Panel 2 – Qiagen Safety Information
Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.
Primary source: Téléchargez le courrier de la société Shimadzu (10/09/2026)
Translated From French
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A field safety notice (FSN) was issued requiring users of the X-Ray High Voltage Generators UD150B-40, UD150V-40, UD150L-40, and others to identify the device and cut the circuit breaker.
These measures are vital to prevent potential safety risks associated with the use of the mentioned medical devices, which are crucial for medical imaging.
Users must identify the affected devices and take immediate action to cut the power supply by turning off circuit breakers. These actions should remain in effect for a period of 3 years.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Users must identify the affected devices and take immediate action to cut the power supply by turning off circuit breakers. These actions should remain in effect for a period of 3 years.
A safety issue has been identified concerning various X-ray high voltage generator models and related digital angiography systems produced by Shimadzu. Detailed instructions for users are provided to ensure safety until interventions are completed.
What changed: A field safety notice (FSN) was issued requiring users of the X-Ray High Voltage Generators UD150B-40, UD150V-40, UD150L-40, and others to identify the device and cut the circuit breaker.
Why it matters: These measures are vital to prevent potential safety risks associated with the use of the mentioned medical devices, which are crucial for medical imaging.
Practical implication: Users must identify the affected devices and take immediate action to cut the power supply by turning off circuit breakers. These actions should remain in effect for a period of 3 years.
Published from the regulator source ingestion pipeline after PV impact triage.
Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.
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Monitoring of the affected batches will be essential to ensure regulatory compliance and consumer safety, alongside implementation of any necessary recall procedures.
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