Other Medical Devices

The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.

Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

The labeling was missing information on sterilization and prohibition of reuse.

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

The belt may fail at lower loads than the labeled 600lbs.

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

Product has a lack of sterility assurance

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.