Fresh Recalls

Instrumentation Laboratory recalls

8 recent recalls on record for Instrumentation Laboratory in connected official government data as of September 7, 2026 at 6:00 AM UTC.

Models with recalls

Brand Name (5)GEM Premier 5000 PAK Part Numbers (1)GEM Premier 5000 with IQM2 Model/Catalog Number (1)GEM Premier 7000 with iQM3 Part Numbers (1)

All Instrumentation Laboratory recalls

FDA Class II · Medical device · August 12, 2026

GEM Premier 5000 PAK Part Numbers recall — 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…

Official ID Z-2900-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

GEM Premier 7000 with iQM3 Part Numbers recall — 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…

Official ID Z-2899-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — 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.

Official ID Z-2826-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — 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.

Official ID Z-2825-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — 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.

Official ID Z-2824-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — 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.

Official ID Z-2823-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

Brand Name recall — 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.

Official ID Z-2822-2026 · Official record ↗

FDA Class II · Medical device · August 5, 2026

GEM Premier 5000 with IQM2 Model/Catalog Number recall — 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.

Official ID Z-2821-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.