Reason: Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Distributed: US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.Reason: Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Distributed: US-wide distributionReason: The impacted lot may not meet the required tensile strength specification.
Distributed: USReason: The impacted lot may not meet the required tensile strength specification.
Distributed: USReason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Distributed: United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, UtahReason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Distributed: United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, UtahReason: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
Distributed: US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.Reason: Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
Distributed: U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: NoneReason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Distributed: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Distributed: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.