FDA-Device2026-03-18Class IIPROCESSING DEFECT

Instrumentation Laboratory GEM Premier 5000 cartridges recalled for repeated ejection errors

OTHERNationwide distributionMedical devices

What this means

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated "Process Control Solution Not Detected" errors during startup, causing the cartridges to be ejected and requiring replacement. This can delay test results. The affected cartridges are lot numbers 251114K, 251205K, and 251215D (Part No. 00055430011).

If you operate a GEM Premier 5000, monitor cartridge performance during warm-up
If a cartridge is repeatedly ejected, replace it with a new one
Plan ahead for potential operational delays if multiple cartridges fail in sequence
Contact Instrumentation Laboratory if you have questions about affected lot numbers

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

All ages

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

25 units

Manufactured in

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

Products

GEM Premier 5000; Part No. 00055430011.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2026

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