GEM Premier 5000; Part No. 00055415005. Recall
Issued March 18, 2026 · Instrumentation Laboratory
In March 2026, Instrumentation Laboratory recalled the GEM Premier 5000; Part No. 00055415005., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using GEM Premier 5000; Part No. 00055415005. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Instrumentation Laboratory to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Instrumentation Laboratory
- Category
- Health
- Recall date
- March 18, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland,
- Recall number
- FDA-Z-1533-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Instrumentation Laboratory has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.