FDA-Device2026-03-18Class IIPROCESSING DEFECT

Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors

OTHERNationwide distributionMedical devices

What this means

Certain GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may eject repeatedly during startup due to detection errors. This can cause delays in test results and require staff to replace cartridges multiple times. The issue affects specific lot numbers manufactured between October and December 2025.

Check if your GEM Premier 5000 uses cartridges from the affected lot numbers (251021K through 251231G)
Contact Instrumentation Laboratory if you have affected cartridges to discuss options
Plan for potential delays in test turnaround times and have backup cartridges available
Continue using cartridges that pass the AutoPAK Validation check after startup

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.

Affected count

1,607 units

Manufactured in

180 Hartwell Rd, N/A, Bedford, MA, United States

Products

GEM Premier 5000; Model No. 00055430010.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2026

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