FDA-Device2026-03-18Class IIPROCESSING DEFECT

Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for detection errors

OTHERNationwide distributionMedical devices

What this means

Some GEM Premier 5000 PAK cartridges (Part No. 00055407510) may fail to detect process control solution during warm-up, causing the cartridge to eject. This can require staff to insert a new cartridge and may delay test results. Most cartridges work normally, but some lots are experiencing repeated ejection problems.

If you operate a GEM Premier 5000, check if your cartridge lot number matches the recalled list
Monitor for repeated cartridge ejections during warm-up
Keep extra cartridges on hand to minimize testing delays if ejections occur
Contact Instrumentation Laboratory if you experience consecutive cartridge failures

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

1,126 units

Manufactured in

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

Products

GEM Premier 5000 PAK; Part No. 00055407510.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2026

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