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Instrumentation Laboratory Recalls

Overview of recall records associated with Instrumentation Laboratory, including dates, categories and classifications where available.

28recall records
Aug 12, 2026latest record date
Mar 18, 2026earliest record date

Recall history in this database

Classification mix: Class II: 28.

Medical DeviceAug 5, 2026

GEM Premier 5000 recall — FDA Z-2825-2026

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.

Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceAug 5, 2026

GEM Premier 5000 recall — FDA Z-2823-2026

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.

Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceAug 5, 2026

GEM Premier 5000 recall — FDA Z-2824-2026

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.

Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceAug 5, 2026

GEM Premier 7000 with iQM3 recall — FDA Z-2822-2026

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.

Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceAug 5, 2026

GEM Premier 5000 recall — FDA Z-2826-2026

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.

Class IIFDA: OngoingInstrumentation Laboratory

Understanding this recall history

This page summarizes recall records in which the official source identifies Instrumentation Laboratory as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.