FDA recall Z-2822-2026

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

Status

Ongoing

Initiation date

2026-05-08

Report date

2026-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

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