GEM Premier 5000 Recall Issued for Blood Analyzer Systems
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Instrumentation Laboratory is recalling 67 GEM Premier 5000 portable blood analyzer systems nationwide due to a potential bar code reader issue that could assign patient results to incorrect IDs.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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What Happened
Instrumentation Laboratory initiated a voluntary recall of GEM Premier 5000 systems after identifying a potential for Bar Code Reader (BCR) wands to assign patient results to an incorrect patient ID.
Which Products Are Affected
The recall involves 67 units of the GEM Premier 5000 portable blood analyzer system (Model/Catalog Number: 00024019255; UDI: 08426950870227) distributed in the United States. Affected serial numbers are: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. The recall also affects the Bar Code Reader (BCR) Wand (Part No. 00024015859; UDI No. 08426950869634) that received a configuration update on or after April 8, 2026. Distribution was US Nationwide.
What You Should Do
Consumers with affected units should contact Instrumentation Laboratory for additional information regarding the recall.
Why This Matters
The potential misassignment of patient test results could impact clinical decision-making.
Source
FDA Recall Number: Z-2824-2026. Class II recall initiated May 8, 2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (1,661 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.