🏥 Medical Devices • 6,627 recalls
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.
Zimmer Manufacturing B.V.
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
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.
Zimmer Manufacturing B.V.
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.
Diamedix
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.
Zimmer Manufacturing B.V.
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.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
Potential of an allergic reaction in a patient with nickel sensitivity.
Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.