GEM Premier 7000 with iQM3 PAK (BG/COOX 150 Tests) 00077415004Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K223608); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

   Z-2899-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223608. One submission often covers many models, so check the product and lot details in each record.

• Z-2822-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality co