GEM Premier 5000; Part No. 00055445010 & 00055445011.

Reason: 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.

Code information: Part number: 00055445010; UDI: 08426950807810; Lots No.: 251023N, 251024J, 251114K, 251117A, 251117AC, 251117AE, 251117F, 251117I, 251117J, 251117Y, 251118A, 251119A, 251120U, 251121Q, 251121S, 251121T, 251121W, 251121X, 251124K, 251124O, 251124U, 251125I, 251126C, 251126D, 251202H, 251203L, 251203M, 251204R, 251204S, 251205K, 251205L, 251208J, 251208L, 251215D, 251215W, 251215X, 251216S, 251216V, 251217W, 251217X, 251218R, 251218Y, 251219B, 251219C, 251219E, 251219H, 251219I, 251219P, 251219Q, 251223B, 251223D, 251223F, 251223K, 251229AL, 251229D, 251229E, 251229F, 251229S, 251229U, 251230R, 251231B, 251231D, 251231E, 251231H, 251231M. Part number: 00055445011 UDI: 08426950807827 Kits distributed in US: 96 Lots No.: 251117L, 251118O, 251124K, 251125I, 251201X, 251202G, 251203M, 251204O, 251223K, 251229W, 251230A.

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.