GEM Premier 5000; Part No. 00055430008.
Pending LLM rewrite. Source: FDA_DEVICE Z-1538-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- GEM Premier 5000; Part No. 00055430008.
- Manufacturer
- Instrumentation Laboratory
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Part number: 00055430008
- UDI: 08426950807735
- Lots No.: 251106X
- 251110AF
- 251202P
- 251203Q
- 251215J
- 251229AG
- 251229X
- 251230P.
Distribution
Distributed nationwide across the United States.
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