The FDA has initiated a Class II device recall for GEM Premier 5000 PAKs (Part No. 00055407504) manufactured by Instrumentation Laboratory. The recall is prompted by confirmed customer complaints indicating an increased incidence of Process Control Solution Not Detected (PCSND) errors during the warm-up phase, which can lead to GEM PAK ejection. This issue necessitates the insertion of new cartridges.

This recall impacts worldwide distribution, including the United States and several other countries. Healthcare providers using the GEM Premier 5000 system should be aware of this potential malfunction and follow manufacturer instructions for addressing PCSND errors and cartridge replacement. While no specific compliance deadline is listed, the ongoing nature of the recall implies immediate attention is required for affected devices.