FDA Class II Device Recall: GEM Premier 5000

The FDA has classified a Class II device recall (Z-1542-2026) concerning Instrumentation Laboratory's GEM Premier 5000, part number 00055445008. The recall is due to confirmed customer complaints indicating an increased incidence of 'Process Control Solution Not Detected' (PCSND) errors during warm-up, which can lead to GEM PAK ejection and require re-insertion. This issue affects the reliability and potentially the accuracy of patient results.

This recall is ongoing and has worldwide distribution, including the United States and several other countries. Healthcare providers and facilities using the GEM Premier 5000 should be aware of this recall and review their internal procedures for managing device errors and cartridge replacements. While the document does not specify a compliance deadline, entities in possession of affected devices should consult Instrumentation Laboratory's recall instructions and the FDA's enforcement database for further guidance on remediation and reporting requirements.