GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with a potential risk of harm due to inaccurate clinical readings, though no injuries have been reported in the source text.
Plain-English summary
Instrumentation Laboratory is recalling specific lots of the GEM Premier 7000 with iQM3, a portable critical care system used by healthcare professionals to analyze lithium heparinized whole blood samples.
The recall is due to the active ingredient concentration in the lysing bag solution of certain PAK lots failing to meet established manufacturing specifications. This malfunction could lead to delayed recognition and management of abnormalities related to Co-Oximetry and total bilirubin, as well as their subsequent effects.
This recall affects 32 units distributed worldwide, including in the United States (AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV), China, Germany, and Italy. Healthcare professionals should follow manufacturer instructions regarding the affected PAK lots.
The recalled product
- 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 h
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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