# FDA recall Z-2822-2026

> **Instrumentation Laboratory** · Class II · device recall initiated 2026-05-08.

## 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 for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2822-2026
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-08
- **Report date:** 2026-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2822-2026

## Citation

> AI Analytics. FDA recall Z-2822-2026. Retrieved 2026-09-01 from https://api.ai-analytics.org/recall/Z-2822-2026. Source: US FDA. Licensed CC0.

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