FDA Class II Device Recall: GEM Premier 5000 PAK

The FDA has initiated a Class II device recall for Instrumentation Laboratory's GEM Premier 5000 PAK (Part No. 00055360011) due to Process Control Solution Not Detected (PCSND) errors. The recall affects worldwide distribution, including the US.

FDA Class II Device Recall: Beckman Coulter DxC 700 AU

The FDA has issued a Class II recall for Beckman Coulter's DxC 700 AU device, identified as recall Z-1552-2026. The recall is ongoing due to potential delays in results caused by issues with the SQL Server 2022 Express software when open for extended periods, which can lead to database errors.

Physio-Control Infant Electrode Recall (Class II)

The FDA has initiated a Class II recall for Physio-Control Infant/Child Reduced Energy Defibrillator Electrodes due to delamination issues. The recall affects worldwide distribution, including nationwide distribution within the U.S. The ongoing recall is classified as a Class II event, indicating potential for adverse health consequences.

Medartis AG Class II Recall: APTUS 2.5 TriLock Screw Mix-up

The FDA has issued a Class II recall for Medartis AG's APTUS 2.5 TriLock Screw due to a mix-up between 2.5mm and 2.8mm screw lots. This recall impacts distribution worldwide, including nationwide distribution in Indiana and Pennsylvania.

Class II Recall: GEM Premier 5000 PAKs due to PCSND Errors

The FDA has issued a Class II recall for Instrumentation Laboratory's GEM Premier 5000 PAKs (Part No. 00055407508) due to an increased incidence of Process Control Solution Not Detected (PCSND) errors. The recall is ongoing and has worldwide distribution.

FDA Class II Device Recall: GEM Premier 5000

The FDA has initiated a Class II device recall (Z-1542-2026) for Instrumentation Laboratory's GEM Premier 5000 due to customer complaints of Process Control Solution Not Detected errors. The recall impacts worldwide distribution, including the US.

Class II Device Recall: GEM Premier 5000 PAK Cartridges

The FDA has initiated a Class II device recall for GEM Premier 5000 PAK cartridges (Part No. 00055407510) due to an increased incidence of 'Process Control Solution Not Detected' errors. The recall affects worldwide distribution, including the US.

FDA Class II Device Recall: GEM Premier 5000 PAK

The FDA has issued a Class II device recall for Instrumentation Laboratory's GEM Premier 5000 PAK due to an increased incidence of Process Control Solution Not Detected (PCSND) errors. This recall affects worldwide distribution, including the US.

Class II Device Recall: GEM Premier 5000

The FDA has issued a Class II device recall for Instrumentation Laboratory's GEM Premier 5000, Part No. 00055445004. The recall is due to an increased incidence of 'Process Control Solution Not Detected' errors with the GEM PAK cartridges, potentially leading to GEM PAK ejection. The device is distributed worldwide.

FDA Class II Device Recall: GEM Premier 5000

The FDA has initiated a Class II device recall for Instrumentation Laboratory's GEM Premier 5000, Part No. 00055415010. The recall is due to customer complaints indicating an increased incidence of 'Process Control Solution Not Detected' errors with the GEM PAK cartridges, potentially leading to device malfunction. The product has been distributed worldwide.