FDA Classifies Recall of GEM Premier 7000 Blood Analyzers as Class II Hazard
FDA enforcement records show an ongoing recall of four GEM Premier 7000 portable blood analyzers due to barcode reader wand issues.
4 reports on this incident · first at Aug 20, 2026, 9:10 a.m. ET
Earlier reports
Aug 20, 2026, 9:53 a.m. ET
FDA Classifies GEM Premier 7000 Recall as Class II Hazard
On August 5, 2026, the U.S. Food and Drug Administration classified the recall of GEM Premier 7000 portable blood analyzers as Class II. The FDA defines Class II as its middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote.
The recall, initiated on May 8, 2026, involves GEM Premier 7000 with iQM3 portable blood analyzers manufactured by Instrumentation Laboratory of Bedford. The affected units carry Model/Catalog Number 00000015279 and UDI No. 08426950869634. According to official FDA documentation, 4 units received US Nationwide distribution under recall number Z-2822-2026, and the recall status remains ongoing.
An official FDA enforcement report states the action was initiated 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 agency's enforcement database lists no other enforcement action for Instrumentation Laboratory.
Aug 20, 2026, 9:23 a.m. ET
FDA Closes Recall of GEM Premier 7000 Blood Analyzers
The Food and Drug Administration has closed its enforcement action regarding four GEM Premier 7000 with iQM3 portable blood analyzers, indicating that the agency considers the recall carried out. The action applies to units with UDI No. 08426950869634 and Model/Catalog Number 00000015279.
The recall was initiated on May 8, 2026, and listed in an FDA enforcement report on August 5, 2026, by Instrumentation Laboratory of Bedford for 4 US nationwide distributed units. According to the FDA enforcement report, the recall was conducted 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 classified the recall as Class II, a category defined by the agency for situations where product exposure may cause temporary or medically reversible harm, and where the probability of serious harm is remote. The FDA database lists no other enforcement actions for Instrumentation Laboratory.
Aug 20, 2026, 9:10 a.m. ETFirst report
FDA Records Show Ongoing Recall of GEM Premier 7000 Blood Analyzers
On August 5, 2026, FDA official records reported an ongoing recall of four GEM Premier 7000 with iQM3 portable blood analyzers distributed nationwide across the United States. The action was initiated on May 8, 2026, by Instrumentation Laboratory, located in Bedford, under recall number Z-2822-2026.
The recall affects the GEM Premier 7000 with iQM3 model/catalog number 00000015279, with UDI No. 08426950869634. Intelligent Quality Management 3 (iQM3) serves as the quality control and assessment system for the device. According to the FDA enforcement record, the action 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 agency classifies the event as a Class II recall. The FDA defines Class II as its middle category, used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. Agency records list no other recall history or enforcement actions for Instrumentation Laboratory. The recall status remains open and ongoing.
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- Version 120 Aug 2026, 14:23current
First published.
- Version 120 Aug 2026, 13:10current
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- Version 120 Aug 2026, 13:53current
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- Version 120 Aug 2026, 13:23current
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