Other Medical Devices

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Ultrasound gel mislabeled with inappropriate use.

Ultrasound gel mislabeled with inappropriate use.

Ultrasound gel mislabeled with inappropriate use.

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

Ultrasound gel mislabeled with inappropriate use.

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

The incorrect product labeling was applied to the product indicating the wrong size of product.

Ultrasound gel mislabeled with inappropriate use.

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Ultrasound gel mislabeled with inappropriate use.

Manufactured lenses are not covered by existing FDA approval

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Manufactured lenses are not covered by existing FDA approval