FDA (Devices) recall action 99115
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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 agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.
Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.
Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.
Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.
Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.