Instrumentation Laboratory: GEM Premier 5000; Model No. 00055430010.

Company / brand

Instrumentation Laboratory

Product

GEM Premier 5000; Model No. 00055430010.

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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 initiated

2026-01-20

Code info

Part number: 00055430010; UDI: 08426950807759; Lots No.: 251021K, 251027AA, 251110AH, 251114K, 251114O, 251114P, 251114Y, 251117AA, 251117AC, 251117AG, 251117AM, 251117AN, 251117P, 251117T, 251117V, 251117Y, 251118A, 251118B, 251118R, 251118X, 251119A, 251120R, 251120U, 251121Q, 251124O, 251124Q, 251125I, 251126S, 251126T, 251126U, 251201W, 251201X, 251202G, 251202H, 251203L, 251204R, 251205L, 251208N, 251211W, 251215D, 251215Z, 251216O, 251216S, 251217L, 251217V, 251218AB, 251218B, 251218X, 251218Y, 251219A, 251219O, 251222AE, 251222E, 251222F, 251222K, 251222M, 251222P, 251222Z, 251223A, 251223B, 251223C, 251223I, 251223M, 251223O, 251229D, 251229E, 251229I, 251229S, 251231B, 251231G.

Product quantity

1,607 units

Voluntary mandated

Voluntary: Firm initiated

City

Bedford

State

MA

Country

United States

Event id

98349

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