Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Instrumentation Laboratory
The hazard
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 Class II recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 20106039Model 19052933Model 20116415Model 20064792Model 22062065Model 22062067Model 19103490Model 22092716Model 22102881Model 18112339Model 19012518Model 20126582Model 20075256Model 20064794Model 20106036Model 24016057Model 21088758Model 21088759Model 18061910Model 24016081Model 24016108Model 24108036Model 24108044Model 24067370Model UDI No. 08426950869634UPC 08426950870227UPC 08426950869634Would you have heard about this one?
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