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 t
Instrumentation Laboratory
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Part No.00077407508 UDI-DI 00195226000764 Lot 260504EModel Part No. 00077407510 UDI-DI 00195226000665 Lot 260505BModel Part No. 00077415004 UDI-DI 00195226000856 Lot 260505AModel Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505AModel Part No. 00077415010 UDI-DI 00195226000658 Lot 260505CModel Part No. 00077430010 UDI-DI 00195226000641 Lot 260505BUPC 00195226000764UPC 00195226000665UPC 00195226000856UPC 00195226000757UPC 00195226000658UPC 00195226000641Would you have heard about this one?
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