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Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Manag

Recall date: 2026-08-05 · Source: FDA_DEVICE
Brand / Firm
Instrumentation Laboratory
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
Reason for recall
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.
Units affected
4 US
Description
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
View official recall notice →