All recalls8,506 total
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product was made on equipment that test positive for Listeria .
Shrimp may be contaminated with Cesium-137 (Cs-137).
Lack of assurance of sterility.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Shrimp may be contaminated with Cesium-137 (Cs-137).
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Potential Salmonella contamination.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Polyaxial screws do not meet performance standards.
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)
No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)
Contains elevated levels of lead
Possible positive Listeria monocytogenes. Firm tested one lot of sliced green onions in-house and found Listeria monocytogenes.