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The hand crank handle may separate and detach from the unit during use.
Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
Out of specification lens curve
Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
Medical device for patient treatment does not meet electrical safety standards.
Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.