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The film was incorrectly notched.
A localized fog pattern appears on the film.
The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
Some units exhibit weak false-positive reactions with some negative patient serum
Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings..
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
May have tobramycin over-recovery at the trough level.
After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product.
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.