Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000
- Recalling company
- Instrumentation Laboratory
- Product
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 8, 2026
- Reported
- Aug 5, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 67
- Lot / codes
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- Company location
- Bedford, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2824-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2824-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.