FDA Class II Recall of GEM Premier 5000 PAK

FDA: Device Recalls Class II

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA has classified a voluntary Class II recall initiated by Instrumentation Laboratory for their GEM Premier 5000 PAK (Part No. 00055360004). The recall is due to an increased incidence of Process Control Solution Not Detected (PCSND) errors, which can lead to GEM PAK ejection and potential operational disruptions. The recall affects 51 units distributed worldwide.

View original document View source feed page

What changed

Instrumentation Laboratory has initiated a voluntary Class II recall for their GEM Premier 5000 PAK (Part No. 00055360004) due to an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up. These errors can cause GEM PAK ejection, requiring replacement and potentially delaying patient results. While the device may remain in use if it passes AutoPAK Validation, consecutive ejections can disrupt operations. The recall affects 51 units distributed globally.

Healthcare providers using the GEM Premier 5000 system should be aware of this recall and the potential for operational disruptions. While the FDA has classified this as a Class II recall, indicating a lower probability of serious adverse health consequences, facilities should review their inventory and consider advance planning to mitigate potential impacts on turnaround times and patient management. The recall is ongoing, and affected lot numbers include 251113U, 251201AI, 251202Q, 251223E, 251223P, and 251229X.

What to do next

Review inventory for affected GEM Premier 5000 PAK units and lot numbers.
Assess potential operational disruptions and implement mitigation strategies.
Consult Instrumentation Laboratory for specific guidance on handling the recalled product.

Source document (simplified)

json { "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Bedford", "state": "MA", "country": "United States", "classification": "Class II", "openfda": { }, "product_type": "Devices", "event_id": "98349", "recalling_firm": "Instrumentation Laboratory", "address_1": "180 Hartwell Rd", "address_2": "N/A", "postal_code": "01730-2443", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "distribution_pattern": "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.", "recall_number": "Z-1524-2026", "product_description": "GEM Premier 5000 PAK, Part No. 00055360004.", "product_quantity": "51 units", "reason_for_recall": "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.", "recall_initiation_date": "20260120", "center_classification_date": "20260310", "report_date": "20260318", "code_info": "Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X." } ] }