FDA DeviceClass IINotable

FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po

Date: 2026-08-05
Brand: Instrumentation Laboratory
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

3

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