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Instrumentation Laboratory recalls Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intel
Recalled August 5, 2026 · FDA recall Z-2822-2026 · Instrumentation Laboratory
Hazard
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. · FDA Class II
Units
4 US
Sold at
US Nationwide distribution.
Description
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Product
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
Manufacturer(s)
Instrumentation Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →