DeviceSignal · Recall classified
Instrumentation Laboratory
FDA classified a device recall on 2026-08-06 · Class II · Z-2899-2026
EventRecall classified
Effective2026-08-06
ClassificationClass II
On 2026-08-06 the FDA classified a device recall from Instrumentation Laboratory as Class II. Product: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004…. Recall Z-2899-2026. The firm initiated it on 2026-05-21. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2899-2026
- Classification
- Class II
- Classified on
- 2026-08-06
- Initiated on
- 2026-05-21
- Firm
- 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 specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2899-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
491dcf4511b70359a8800c973434fbb61ffe541573b26dfd3528cdc0344112ac- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)