FDA DeviceClass IINotable
FDA Recall: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008
Description
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.
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.
Remedy
32 units
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