Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 units with specific part numbers due to potential delayed detection of blood abnormalities. Affected units may require replacement to prevent missed health issues.
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Instrumentation Laboratory is recalling specific models of the GEM Premier 7000 with iQM3 blood analyzer because the lysing bag solution may not work correctly. This could lead to delayed detection of serious blood conditions like low oxygen levels or high bilirubin, which might cause health problems if not caught early.
The lysing bag solution in specific batches of the GEM Premier 7000 with iQM3 may not contain the correct active ingredient concentration. This could cause the device to miss detecting critical blood conditions like low oxygen levels or high bilirubin, which might lead to serious health issues if not identified promptly.
Healthcare professionals using the GEM Premier 7000 with iQM3 blood analyzer in clinical settings are most at risk. Patients receiving blood tests with these specific units could experience delayed diagnosis of critical blood abnormalities.
Check for part numbers: 00077407508, 00077407510, 00077415004, 00077415008, 00077415010, or 00077430010. These units were sold with specific lots (260504E, 260505A, 260505B, 260505C) between May 2023 and early 2024.
Review your GEM Premier 7000 with iQM3 unit's part number and lot number to confirm if it's affected.
The lysing bag solution in specific batches of the GEM Premier 7000 with iQM3 may not contain the correct active ingredient concentration, which could lead to delayed detection of blood abnormalities.
Check your unit's part number and lot number to see if it's affected. If it is, contact Instrumentation Laboratory for guidance.
The recall is for potential delayed detection of blood abnormalities, not a direct risk of injury. However, missing critical blood conditions could lead to health problems.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-2899-2026 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-2899-2026 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.
