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High mold, yeast, and total viable count
Product may be contaminated with mold.
Contamination with foreign substance matter
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies
7F sheath introducers labeled as 7.5F
Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
undeclared peanuts, almonds and pecans
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Products may contain undeclared sesame