Instrumentation Laboratory 2026-08-05 Health serious FDA
Health · FDA · Recall #FDA-Z-2825-2026
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:… Recall
Issued August 5, 2026 · Instrumentation Laboratory
In August 2026, Instrumentation Laboratory recalled the Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Instrumentation Laboratory to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Instrumentation Laboratory
- Category
- Health
- Recall date
- August 5, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2825-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Instrumentation Laboratory has 6 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.