Medium risk Drugs & MedicationsClass II

Instrumentation Laboratory Recall

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Updated May 8, 2026

Instrumentation Laboratory is recalling Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system. 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.

Is the Instrumentation Laboratory recalled? Yes. This product was recalled by FDA on May 8, 2026. Details below.

What is recalled

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The 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.

Brands affected

Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2824-2026
Classification
Class II
Recalled
May 8, 2026
Read the official notice

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