Official recall record
GEM Premier 5000; Part No: 00055415011.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-01-20
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Instrumentation Laboratory
What the authority reported
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
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.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-05-21 · US FDA — Medical Devices
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 000 - 2026-05-21 · US FDA — Medical Devices
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 0007741501
All 18 official recall notices naming Instrumentation Laboratory on this site →