GEM Premier 7000 with iQM3 Part Numbers 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.

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.

Quantity: 32 units

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Instrumentation Laboratory, Bedford, MA

Date

Wednesday, August 12

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
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

Recall number

Z-2899-2026

Source

U.S. Food and Drug Administration