Instrumentation Laboratory recalls GEM Premier 5000 and 7000 blood analyzers with specific bar code reader wands that may assign patient results to the wrong ID. Affected units have model numbers starting with 00024019255 or 00000015279.
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 and 7000 blood analyzers with specific bar code reader wands that could assign patient results to the wrong patient ID. This risk could lead to serious medical errors if the system misidentifies patients.
The bar code reader wands used with these analyzers may assign patient results to the wrong patient ID after receiving a configuration update on or after April 8, 2026. This could cause serious medical errors if the system misidentifies patients during blood test processing.
Healthcare facilities using the GEM Premier 5000 with IQM2 model (00024019255) or GEM Premier 7000 with iQM3 model (00000015279) are most at risk. Patients receiving blood tests through these systems may be affected if the bar code reader wand misidentifies their ID.
Check for GEM Premier 5000 with IQM2 model number 00024019255 or GEM Premier 7000 with iQM3 model number 00000015279. The affected bar code reader wands received a configuration update on or after April 8, 2026.
Verify the bar code reader wand model number is 00024015859 and was updated on or after April 8, 2026.
Reach out to Instrumentation Laboratory for guidance on correcting the issue with the bar code reader wand.
The bar code reader wand may assign patient results to the wrong patient ID after receiving a configuration update on or after April 8, 2026, which could cause serious medical errors.
GEM Premier 5000 with IQM2 model number 00024019255 and GEM Premier 7000 with iQM3 model number 00000015279.
No, but you should check if your bar code reader wand was updated on or after April 8, 2026, and contact Instrumentation Laboratory for guidance.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-2821-2026 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-2821-2026 from Instrumentation Laboratory. 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.
