All recalls8,504 total
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
Potential contamination due to leachable lead.
Undeclared Soy Protein Concentrate
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Products may contain contamination, which may result in a darker or brown media color.
Contaminated with Salmonella
Contaminated with Salmonella
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
Devices are not suitable for organ transplant.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Devices are not suitable for organ transplant.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Devices are not suitable for organ transplant.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Undeclared FD&C Red #40
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
Contaminated with Clostridium botulinum
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.