Instrumentation Laboratory Recall: GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory Recall: GEM Premier 5000 PAK, Part No. 00055360004. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Instrumentation Laboratory; Product: GEM Premier 5000 PAK, Part No. 00055360004.; Reason for recall: Confirmed customer complaints indicating that GEM PAKs (ca
| Recalling firm | Instrumentation Laboratory |
|---|---|
| Product | GEM Premier 5000 PAK, Part No. 00055360004. |
| Reason for recall | 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, pot |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, |
| Recall initiated | 20260120 |
| Recall number | Z-1524-2026 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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