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Moderate riskFDA DeviceClass II

Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for increased error rate

Instrumentation Laboratory has identified that some GEM PAK cartridges (part no. 00055407511) for the GEM Premier 5000 blood analyzer may fail quality checks more frequently during startup, causing the cartridge to be ejected. This can delay test results and may require multiple cartridge replacements. The GEM Premier 5000's built-in quality monitoring system (iQM2) will catch and reject any cartridges that do not pass validation, so cartridges that complete the validation process remain safe to use.

From the FDA notice · Read the official notice ↗ · All Instrumentation Laboratory recalls

What to do

  1. Monitor GEM Premier 5000 startup for repeated cartridge ejection errors
  2. If you experience consecutive ejection errors, have replacement cartridges ready to minimize delays
  3. Ensure your iQM2 quality control program is active and functioning
  4. Contact Instrumentation Laboratory if you experience unusual error patterns
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
GEM Premier 5000 PAK; Part No. 00055407511.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 20 products — see all of them.

Details

Units affected
27 units
Illnesses reported
None reported
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Classification
Class II
Recall number
Z-1531-2026

In the FDA's words

Description
GEM Premier 5000 PAK; Part No. 00055407511. 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. Part number: 00055407511; UDI: 08426950807643; Lots No. 251114K, 251201X, 251215D. 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, 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 quantity: 27 units
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.

20 products in this recall

Instrumentation Laboratory GEM Premier 5000 PAKs recalled for test errors

Instrumentation Laboratory is recalling 20 GEM PAK cartridges for the GEM Premier 5000 system. Customers reported that the cartridges may show 'Process Control Solution Not Detected' (PCSND) errors during warm-up, sometimes repeatedly, which ejects the cartridge and requires inserting a new one. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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