bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
All Recalls
95,025 total recalls in our database
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS Mumps IgG (MPG), REF 30218
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
VIDAS SARS-COV-2 IgG, Ref 423834-01
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Medtronic Neuromodulation
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
CRT Motor Youth All-Terrain Vehicles (ATVs)
Unknown Manufacturer
The CRT Motor youth model ATVs do not meet mandatory safety requirements. Children can operate them above the maximum allowed speed, increasing the risk of a crash that can cause serious injuries. In addition, the handlebars pose a laceration hazard should the child rider's body or head impact the handlebars at a high rate of speed such as in a crash.
Native Creation Small Wool Sweaters
Unknown Manufacturer
Paint on the zipper pull contains levels of lead that exceed the maximums allowed. Excessive levels of lead can be toxic or cause other health problems to young children if the paint is ingested.
Potential for metal in product
Cesarina Cookies, Assorted Cookies, Net Weight 16oz (453.59g)
Cesarina Bakery
Undeclared Milk
Kimberley's bakeshoppe vanilla mini Frosted soft Sugar Cookies 9.4 oz. UPC 7 70981 30310 9
GIVE AND GO
Potential for metal in product
Potential for metal in product
Potential for metal in product
Potential for metal in product