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GEM Premier 3500 3000 iQM BG HCT (75 TEST)

INSTRUMENTATION LABORATORY COMPANY · Model 00026407584 · UDI-DI 08426950511540

CHL Prescription

510(k) clearances

2,419

Adverse events (49 deaths)

185

Recalls

Facilities

Description

GEM Premier 3500 3000 iQM 4WK - BG HCT (75 TEST)

Recalls

Date	Firm	Reason
2026-08-18	Radiometer Medical ApS	In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer su
2026-05-21	Instrumentation Laboratory	The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result
2026-05-21	Instrumentation Laboratory	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 malfunctio
2026-05-08	Instrumentation Laboratory	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.
2026-05-08	Instrumentation Laboratory	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.
2026-05-08	Instrumentation Laboratory	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.
2026-05-08	Instrumentation Laboratory	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.
2026-05-08	Instrumentation Laboratory	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.
2026-05-08	Instrumentation Laboratory	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.
2026-04-02	Siemens Healthcare Diagnostics Inc	Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.