FDA Classifies Recall of GEM Premier 5000 Blood Analyzers as Class II

The FDA classified the recall of 21 GEM Premier 5000 blood analyzer systems as Class II on August 5, 2026.

3 reports on this incident · first at Aug 20, 2026, 3:53 a.m. ET

By AI ReporterWritten Aug 20, 2026, 4:52 a.m. ET

On August 5, 2026, the U.S. Food and Drug Administration categorized an recall of GEM Premier 5000 portable blood analyzer systems as a action. The recall, originally initiated on May 8, 2026, by of , involves 21 units distributed nationwide across the United States under recall number . According to FDA guidance, is the agency's middle hazard classification, defined as a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA enforcement records report that the recall was launched due to the potential for Bar Code Reader (BCR) wands used with GEM Premier 5000 and GEM Premier 7000 systems to assign patient results to an incorrect patient ID. The affected product is identified as the GEM Premier 5000 portable blood analyzer system, model/catalog number 00024019255, with UDI No. 08426950869634. FDA database records show no other enforcement actions listed for . The recall status remains .

Earlier reports

Aug 20, 2026, 4:22 a.m. ET
FDA Reports Class II Recall of GEM Premier 5000 Blood Analyzers
On August 5, 2026, the Food and Drug Administration issued an enforcement report detailing an ongoing Class II recall of GEM Premier 5000 portable blood analyzer systems, manufactured by Instrumentation Laboratory in Bedford. The recall, assigned recall number Z-2825-2026, was initiated on May 8, 2026, and involves 21 units distributed nationwide across the United States.
According to the FDA enforcement report, the recall was initiated due to 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 affected portable blood analyzer systems carry the model and catalog number 00024019255 and UDI number 08426950869634.
According to FDA background and definitions, Class II is the agency's middle classification category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database records show no other enforcement actions for Instrumentation Laboratory.
Aug 20, 2026, 3:53 a.m. ETFirst report
FDA Reports Class II Recall for GEM Premier 5000 Blood Analyzers
On August 5, 2026, an official FDA enforcement report announced an ongoing, developing Class II recall initiated on May 8, 2026, by Instrumentation Laboratory of Bedford. The recall, listed under recall number Z-2825-2026, covers 21 units of the GEM Premier 5000 portable blood analyzer system, with Model/Catalog Number 00024019255 and UDI No. 08426950869634, which were distributed nationwide in the United States.
According to the FDA enforcement report, the recall was initiated due to 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 defines a Class II classification as a category where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote.
FDA database records document no other enforcement actions for Instrumentation Laboratory. The agency notes that past enforcement history says nothing about fault in this current action.

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