Recall Z-2899-2026— Instrumentation Laboratory

Name: FDA recall Z-2899-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2026-05-21. It names one FDA 510(k) clearance: K223608. 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..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K223608 — GEM Premier 7000 with IQM3Instrumentation Laboratory Company·cleared 2023-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.