FDA Closes Recall Action for GEM Premier 5000 Blood Analyzer Systems
The agency considers the recall of 67 portable blood analyzer systems carried out.
2 reports on this incident · first at Aug 20, 2026, 7:11 a.m. ET
Earlier reports
Aug 20, 2026, 7:11 a.m. ETFirst report
FDA Posts Class II Recall for GEM Premier 5000 Blood Analyzer Systems
On August 5, 2026, the FDA posted an enforcement report for an ongoing recall initiated on May 8, 2026, by Instrumentation Laboratory, located in Bedford. The developing recall affects 67 units of the GEM Premier 5000 portable blood analyzer system distributed nationwide in the United States.
The recalled product carries the brand name GEM Premier 5000, model/catalog number 00024019255, and UDI number 08426950869634. According to FDA enforcement report Z-2824-2026, the recall was initiated over the 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.
The FDA classified the action as Class II. Class II is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA databases list no other enforcement actions for Instrumentation Laboratory.
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- Version 120 Aug 2026, 11:11current
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- Version 120 Aug 2026, 11:14current
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