Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 000

Recalling company

Instrumentation Laboratory

Product

GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

Reason

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 21, 2026

Reported

Aug 12, 2026

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.

Status

Ongoing

Quantity

32 units

Lot / codes

Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B

Company location

Bedford, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2899-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2899-2026 in the FDA Enforcement Report. Also see FDA recall press releases.