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Finished products were not sterilized.
Reports of broken plug ground pins on AC power cords for patient monitors.
Sterility compromised - incomplete sterile package seal.
Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has shown a diminished expression on B-Cell populations when drawn on EDTA tubes, which may lead to inaccurate interpretation of phenotype results.
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
Product container was labeled incorrectly indicating left femur instead of right.
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
test results may be inaccurate by 0.2 to 0.5 ng/mL
software malfunction. May indicate that the image is flipped when it is not.
There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
Labeling/packaging mix-up.
Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.