Diagnostic Equipment

New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

Mislabeled for size

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot

An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).

When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.

Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Under certain conditions, mass spectrometers may report incorrect quantitative results.

Product contained an incorrect substrate.

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.