Class II
Medical Device Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Instrumentation Laboratory · May 8, 2026
Reason for Recall
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
27
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2823-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.