{"url_path":"/fda/device/recalls/Z-2826-2026","section_key":"summary","section_title":"DEVICE Recall: Instrumentation Laboratory — Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255   Portable blood analyzer system","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-2826-2026%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":124,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2826-2026\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\nBrand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255   Portable blood analyzer system\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  Units distributed in Argentina:   GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897.   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."}