United StatesGEM Premier 5000 PAK cartridges for the GEM Premier 5000 (e.g., Part No. 00055360004 and numerous other listed part numbers and lot codes) are affected and were distributed worldwide. They were recalled because customer complaints confirmed increased Process Control Solution Not Detected (PCSND) errors during warm‑up, which can cause consecutive GEM PAK ejections and may prolong turnaround times. Owners should be aware that consecutive ejections can delay results and may require reassessment of patient management once results are available.
What's being recalled
GEM Premier 5000 PAK, Part No. 00055360004.
GEM Premier 5000 PAK; Part No. 00055360008.
GEM Premier 5000 PAK; Part No. 00055360010.
GEM Premier 5000 PAK; Part No. 00055360011.
GEM Premier 5000 PAK; Part No. 00055407504.
GEM Premier 5000 PAK; Part No. 00055407508.
GEM Premier 5000 PAK; Part No. 00055407510.
GEM Premier 5000 PAK; Part No. 00055407511.
GEM Premier 5000 PAK; Part No. 00055415004.
GEM Premier 5000; Part No. 00055415005.
GEM Premier 5000; Part No. 00055415008.
GEM Premier 5000; Part No. 00055415010.
GEM Premier 5000; Part No: 00055415011.
GEM Premier 5000; Part No. 00055430004.
GEM Premier 5000; Part No. 00055430008.
And 5 more products.
Recalling firm: Instrumentation Laboratory, Bedford, MA, United States.
How to identify it
Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X. Part number: 00055360008; UDI: 08426950807575; Lot No. 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X. Part number: 00055360010; UDI: 08426950807599; Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q, 251209R, 251215Y, 251217V, 251218AA, 251218T, 251219M, 251222AE, 251222AF, 251222AG, 251222E, 251222F, 251223R, 251223S, 251229H, 251229J, 251229U, 251230A, 251231E, 251231K, 251231L. Part number: 00055360011; UDI: 08426950807605; Lots No.: 251119A. Lot Code: Part number: 00055407504; UDI: 08426950807537; Lots No.: 251111O, 251112P, 251113U, 251114T, 251117AD, 251118D, 251119D, 251120X, 251125S, 251126Q, 251201AI, 251202Q, 251203Q, 251204T, 251209T, 251212O, 251215K, 251216K, 251217I, 251218U, 251219R, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P, 251231F. Part number: 00055407508; UDI: 08426950807612; Lots No.: 251021P, 251106X, 251110AF, 251201AJ, 251202P, 251209S, 251212N, 251215J, 251218W, 251219A, 251223E, 251223M, 251223P, 251229X, 260102F. Part number: 00055407510; UDI: 08426950807636; Lots No.: 251114J, 251117AC, 251117T, 251118B, 251119B, 251121P, 251124O, 251124Q, 251126E, 251201U, 251201V, 251201W, 251202G, 251203H, 251203L, 251204N, 251204O, 251205L, 251208I, 251208J, 251215Y, 251215Z, 251216V, 251217L, 251217X, 251218AA, 251218Y, 251219G, 251219M, 251219N, 251219S, 251222E, 251223D, 251223I, 251223N, 251223O, 251229J, 251229L, 251229U, 251231E. Part number: 00055407511; UDI: 08426950807643; Lots No. 251114K, 251201X, 251215D. Part number: 00055415004; UDI: 08426950807650; Lots No.: 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J, 251219R, 251222U, 251223E, 251229AG, 251229X…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)