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FDA · Medical devices ·

GEM Premier 5000 Product Name recall

Instrumentation Laboratory recalled GEM Premier 5000 Product Name on August 5, 2026 because of 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. It was sold nationwide.

Why it was recalled

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.

What's recalled

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

Quantity: 3

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Instrumentation Laboratory, Bedford, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution.
Status
Ongoing
Recall number
Z-2826-2026
Source
U.S. Food and Drug Administration

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