GEM Premier 5000 Recall
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Instrumentation Laboratory is recalling 27 GEM Premier 5000 portable blood analyzer systems due to a potential issue with Bar Code Reader wands assigning 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.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Instrumentation Laboratory initiated a voluntary recall of the GEM Premier 5000 due to the potential for Bar Code Reader (BCR) wands to assign patient results to an incorrect patient ID.
Which Products Are Affected
The recall affects the GEM Premier 5000 portable blood analyzer system, model/catalog number 00024019255, part number 00024019255, UDI 08426950870227. A total of 27 units are involved, distributed nationwide in the United States. Affected serial numbers are: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. The recall also involves the Bar Code Reader (BCR) Wand, part number 00024015859, UDI 08426950869634, that received a configuration update on or after April 8, 2026. The recall number is Z-2823-2026.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
This Class II recall addresses a device malfunction that could result in incorrect patient result assignment.
Source
FDA recall Z-2823-2026: https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,288 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.