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 25100462Model 25110522Model 25100472Model 25101897Model 25101920Model 25101931Model 25122029Model 26012032Model 25122030Model 26012033Model 26012043Model 25110523Model 25110536Model 25120550Model 25069638Model 23101109Model 24011137Model 25081799Model 25081797Model 25091839Model 25091840Model 25091864Model 25091870Model 25091868Model 25091873UPC 08426950870227UPC 08426950869634Would you have heard about this one?
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