Instrumentation Laboratory recalls GEM Premier 5000 blood analyzers with bar code reader wands that may assign patient results to incorrect IDs. Affected units sold in Spain with specific serial numbers and 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 5000 portable blood analyzers that may assign patient results to the wrong ID when used with bar code reader wands. This could lead to incorrect medical treatment if the system misidentifies a patient's results.
The bar code reader wands (BCR) used with the GEM Premier 5000 and 7000 systems may assign patient results to the wrong ID after a configuration update on or after April 8, 2026. This could cause incorrect medical treatment if the system misidentifies a patient's results.
Healthcare facilities in Spain that use the GEM Premier 5000 blood analyzer system with bar code reader wands updated after April 8, 2026 are most at risk. Patients using these systems may receive incorrect results if the system misidentifies their ID.
Check for the GEM Premier 5000 model with serial numbers listed in the recall (e.g., 25028719, 18021546, etc.) sold in Spain. Also, verify if the bar code reader wand has a configuration update date of April 8, 2026 or later.
Look for the specific serial numbers listed in the recall: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870, and 26010710.
Check if the bar code reader wand has a configuration update date of April 8, 2026 or later.
The bar code reader wands used with the GEM Premier 5000 and 7000 systems may assign patient results to the wrong ID after a configuration update on or after April 8, 2026.
Check the serial numbers listed in the recall and verify if the bar code reader wand has a configuration update date of April 8, 2026 or later.
The recall specifically mentions units distributed in Spain, so no other countries are affected.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-2825-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-2825-2026 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.
