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Showing 5561–5580 of 11714 results

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BCID2 Panel (BioFire) – False Positive Results (2024)

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

Schiff Reagent (EMD Millipore) – Unexpected Color (2024)

This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.

FDAJan 26, 2024AL, IL, MA +5 more• EMD Millipore Corporation

FilmArray GI Panel (BioFire) – False Norovirus Results (2024)

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Moderate

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

VITROS 3600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 5600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 4600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

I.B.S Compression Screw (In2Bones) – Batch Mix-up (2024)

This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

FDAJan 26, 2024Nationwide• In2Bones, SAS 28 Chemin du petit Bois Ecully France

IonoStar Plus (Voco) – Plunger Fitting Error (2024)

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

FDAJan 25, 2024IA, NY, PA +1 more• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

Sofsilk Braided Silk Sutures (Unknown) – Sterilization Exposure (2024)

One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

FDAJan 25, 2024IN

Ionolux (Voco) – Plunger Fitting Error (2024)

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

FDAJan 25, 2024IA, NY, PA +1 more• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

SW Bari Lift (Raye's) – Hoist Performance Issue (2024)

Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.

FDAJan 25, 2024Nationwide• Raye's Inc.

RAPIDSORB IPS Battery Pack (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

Opal Intervertebral Cage (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

Atellica IM EPO Assay (Siemens) – Result Bias (2024)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

FDAJan 24, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Impression Coping (Thommen) – Canal Depth Issue (2024)

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

FDAJan 24, 2024Nationwide• Thommen Medical AG Eschenweg 3 Bettlach Switzerland

TFNA Femoral Nail 9mm (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

VA-LCP Clavicle Plate (Synthes) – Sterilization Uncertainty (2024)

Products not sterilized, sterility cannot be confirmed

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

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