Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distributed: Distribution US nationwide and Canada.Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distributed: Distribution US nationwide and Canada.Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distributed: Distribution US nationwide and Canada.Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distributed: Distribution US nationwide and Canada.Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Distributed: Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Distributed: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.Reason: 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.
Distributed: Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.Reason: Due to incorrect product label (Incorrect product name identified on outer packaging).
Distributed: U.S. Nationwide distribution in the state of TN.Reason: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Distributed: US Nationwide distribution in the states of Hawaii and New York.Reason: A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
Distributed: USA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, ,WI, WV, WY, Canada: AB, ON