Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 models due to potential bar code reader wands assigning patient results to incorrect IDs. Affected units have specific serial numbers and were sold with BCR wands updated after April 8, 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.
Instrumentation Laboratory is recalling GEM Premier 7000 with iQM3 blood analyzers 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.
The bar code reader wands used with the GEM Premier 7000 system may misassign patient results to incorrect patient IDs. This happens when the wands receive a configuration update after April 8, 2026, causing the system to link results to the wrong patient.
Users of GEM Premier 7000 with iQM3 blood analyzers in the U.S. with specific serial numbers are affected. Healthcare facilities using bar code reader wands updated after April 8, 2026, are most at risk.
Check if your GEM Premier 7000 has serial numbers 26012062, 26012065, 26012069, or 26012070. Also, verify if your bar code reader wand was updated after April 8, 2026.
Identify if your GEM Premier 7000 has serial numbers 26012062, 26012065, 26012069, or 26012070.
Confirm if your bar code reader wand was updated after April 8, 2026.
The bar code reader wands used with the GEM Premier 7000 system may assign patient results to the wrong patient ID after a configuration update on or after April 8, 2026.
Check if your GEM Premier 7000 has the specific serial numbers listed or if your bar code reader wand was updated after April 8, 2026. No immediate action is required beyond verification.
The recall record does not specify a fix or remedy for this issue.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-2822-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-2822-2026 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.
