FDA Closes Recall Action for GEM Premier 5000 Blood Analyzer Systems
The agency considers the recall carried out for 27 blood analyzer units involved in a barcode reader identification issue.
2 reports on this incident · first at Aug 20, 2026, 5:44 a.m. ET
Earlier reports
Aug 20, 2026, 5:44 a.m. ETFirst report
FDA Reports Ongoing Recall of GEM Premier 5000 Blood Analyzer Systems
On August 5, 2026, FDA enforcement records published an ongoing recall for portable blood analyzer systems manufactured by Instrumentation Laboratory, based in Bedford. The recall was initiated on May 8, 2026, and involves nationwide distribution across the United States. The action affects 27 units of the GEM Premier 5000 portable blood analyzer system, identified under model/catalog number 00024019255 and UDI number 08426950869634. The FDA categorized the action as a Class II recall under recall number Z-2823-2026. 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. According to FDA records, 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. FDA records list no other enforcement actions for Instrumentation Laboratory.
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- Version 120 Aug 2026, 09:44current
First published.
- Version 120 Aug 2026, 09:53current
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