Instrumentation Laboratory recalls GEM Premier 5000 blood analyzers with specific serial numbers due to potential bar code reader wands assigning patient results to incorrect IDs.
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.
Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzers with certain serial numbers because bar code reader wands used with these devices may assign patient results to the wrong patient ID. This could lead to incorrect medical treatment if not addressed.
Bar code reader wands that received a configuration update on or after April 8, 2026, can incorrectly link patient results to the wrong patient ID when used with the GEM Premier 5000 and GEM Premier 7000 systems. This error may cause medical treatment to be given to the wrong patient.
Healthcare facilities using the GEM Premier 5000 blood analyzer with specific serial numbers in Hong Kong are most at risk. Patients receiving results from these devices may be affected if the bar code reader wand misassigns patient IDs.
Check if your GEM Premier 5000 has a serial number listed in the provided list (e.g., 20106073, 20106039, etc.). Also, verify if the bar code reader wand has a part number of 00024015859 and was updated on or after April 8, 2026.
Verify if your GEM Premier 5000 has a serial number from the list provided in the recall notice.
Ensure the bar code reader wand has been updated before April 8, 2026, to avoid incorrect patient ID assignments.
The recall is due to bar code reader wands that received a configuration update on or after April 8, 2026, potentially assigning patient results to the wrong patient ID when used with the GEM Premier 5000 and GEM Premier 7000 systems.
The GEM Premier 5000 portable blood analyzer with specific serial numbers listed in the recall notice and bar code reader wands with part number 00024015859 that were updated on or after April 8, 2026.
Check your GEM Premier 5000's serial number against the list provided in the recall notice and confirm if your bar code reader wand has a part number of 00024015859 and was updated on or after 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-2823-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-2823-2026 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.
