GEM Premier 5000 Blood Analyzer Recall
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Instrumentation Laboratory is recalling 21 GEM Premier 5000 units due to potential bar code reader wand errors assigning incorrect patient 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, Devices.
What Happened
Instrumentation Laboratory initiated a voluntary recall of the GEM Premier 5000 portable blood analyzer system because of the potential for Bar Code Reader (BCR) wands to assign patient results to an incorrect patient ID.
Which Products Are Affected
The affected product is the GEM Premier 5000 (Brand Name: GEM Premier 5000, Product Name: GEM Premier 5000, Model/Catalog Number: 00024019255, Part number: 00024019255, UDI: 08426950870227). A total of 21 units are involved under recall number Z-2825-2026. Affected accessories are Bar Code Reader (BCR) Wands (Part No. 00024015859; UDI No. 08426950869634) that received a configuration update on or after 8 April 2026. Serial numbers include: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. Distribution was US Nationwide.
What You Should Do
The recall was initiated voluntarily by the firm via letter on 20260508. No additional consumer action steps are specified in the recall notice.
Why This Matters
The Class II recall addresses a potential device malfunction that could result in incorrect patient result assignment during blood analysis.
Source
FDA recall Z-2825-2026, report date 20260805. 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 (1,366 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.