GEM Premier 7000 with iQM3 Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Instrumentation Laboratory recalls four GEM Premier 7000 devices due to potential barcode reader issues that may 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.
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 recall because of the potential for Bar Code Reader (BCR) wands used with the GEM Premier 7000 systems to assign patient results to an incorrect patient ID.
Which Products Are Affected GEM Premier 7000 with iQM3, Model/Catalog Number 00000015279, UDI 0195226000924. Four units distributed in the US: Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected accessory is Bar Code Reader (BCR) Wand, Part No. 00024015859, UDI No. 08426950869634, that received a configuration update on or after 8 April 2026. US Nationwide distribution. Recall number Z-2822-2026. Quantity: 4 US.
What You Should Do Users with affected units should follow instructions provided in the firm's notification letter.
Why This Matters The recall affects a small number of portable blood analyzers used for patient testing across the United States.
Source FDA recall Z-2822-2026, event ID 99115, report date 20260805.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (976 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.