{"url_path":"/fda/device/recalls/Z-2821-2026","section_key":"summary","section_title":"DEVICE Recall: Instrumentation Laboratory — GEM Premier 5000 with IQM2  Model/Catalog Number: 00024019255 and  GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279   Portable blood analyzer system.    Affected Accessory:   Bar Code Reader (BCR) Wand Part No. 00024015859","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2821-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Instrumentation Laboratory"},"word_count":133,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2821-2026\n\n**Recalling firm:** Instrumentation Laboratory\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-08\n**Report date:** 2026-08-05\n\n## Product\nGEM Premier 5000 with IQM2  Model/Catalog Number: 00024019255 and  GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279   Portable blood analyzer system.    Affected Accessory:   Bar Code Reader (BCR) Wand Part No. 00024015859\n\n## Reason\nPotential 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.\n\n## Affected lots\nGEM Premier 5000 Part number: 00024019255, UDI: 08426950870227   GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924    Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634\n\n## Distribution\nUS Nationwide distribution."}