Instrumentation Laboratory recalls Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3
- Recalling company
- Instrumentation Laboratory
- Product
- Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
- 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
- 4 US
- Lot / codes
- GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. 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-2822-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2822-2026 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.