GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 0007743
Summary
The FDA issued a Class II for GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 000774 by Instrumentation 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 .
Details
Source
Device Recall
External ID
Z-2899-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 32 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-21
Company
Bedford, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Instrumentation Laboratory has 47 FDA actions in our database, including 46 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 47 FDA actions in our database, including 46 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2899-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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