GEM Premier 5000 portable blood analyzers with specific serial numbers may incorrectly link patient results to the wrong ID when using bar code reader wands. Affected units were distributed in the UK starting in 2026.
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.
GEM Premier 5000 portable blood analyzers with certain serial numbers may assign patient results to the wrong ID when used with bar code reader wands. This could lead to incorrect medical treatment if the wrong patient's results are acted upon.
Bar code reader wands updated on or after April 8, 2026, may misassign patient results to the wrong ID. This happens because the wand's configuration could link results to the wrong patient's information during blood testing.
Healthcare facilities using the GEM Premier 5000 blood analyzer in the UK with specific serial numbers are most at risk. Patients using the device with affected bar code reader wands could see incorrect results.
Check for serial numbers listed in the recall: 25110547, 25100462, 25110522, and other specific numbers. Affected bar code reader wands received a configuration update on or after April 8, 2026.
Verify if your GEM Premier 5000 has a serial number from the list provided in the recall.
Ensure bar code reader wands were updated before April 8, 2026, to avoid misassigning patient results.
The bar code reader wands updated on or after April 8, 2026, may misassign patient results to the wrong ID, causing potential incorrect medical treatment.
Check your GEM Premier 5000 serial number against the list provided in the recall. Affected bar code reader wands received a configuration update on or after April 8, 2026.
No action is needed if your bar code reader wand was updated before April 8, 2026.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-2824-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-2824-2026 from GEM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
