Reported Aug 12, 2026 · Ongoing
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010…
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- GEM Premier 7000 with iQM3 Part Numbers00077407508 00077407510 00077415004 00077415008 00077415010 00077430010
- Product DescriptionThe 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 codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 0007740750800195226000764UDI-DI 00195226000764 Lot 260504E 0007740751000195226000665UDI-DI 00195226000665 Lot 260505B 0007741500400195226000856UDI-DI 00195226000856 Lot 260505A 0007741500800195226000757UDI-DI 00195226000757 Lot No.260505A 0007741501000195226000658UDI-DI 00195226000658 Lot 260505C 0007743001000195226000641UDI-DI 00195226000641 Lot 260505B - Amount recalled
- 32 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Instrumentation Laboratory recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.