FDA Medical devices recall ·
GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model recall
- Recall number
- Z-2822-2026
- Date
- (initiated May 8, 2026)
- Company / brand
- Instrumentation Laboratory
180 Hartwell Rd, Bedford, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2822-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.