Official recall record
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 0005544
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Instrumentation Laboratory
What the authority reported
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Other recalls from this brand
- 2026-05-21 · US FDA — Medical Devices
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 0007741501 - 2026-01-20 · US FDA — Medical Devices
GEM Premier 5000; Part No. 00055430008.
All 18 official recall notices naming Instrumentation Laboratory on this site →
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