Español
TemporaryFDAOngoing

Can make you unwell for a while. Do not eat it.

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

Check your package for

GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
Why
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.
Distributed
US Nationwide distribution.
Company
Instrumentation Laboratory
Announced
Recall began
Read the official notice

Every recall — food, medication, or medical device — is shown word-for-word from the official FDA or USDA notice, with a link straight to it. Nothing here is summarised, reworded, or filled in. This site is not affiliated with any government agency.

Local Recall