Z-0720-2021 Class II Terminated
FDA device recall Z-0720-2021 was initiated by Beckman Coulter Inc. on December 2, 2020 and is designated Class II. Reason for recall: Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a po… The recall status is terminated (terminated January 3, 2023). Affected quantity: 685 panel boxes (20 panels per box) = 13,700 panels.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- December 2, 2020
- Termination Date
- January 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685 panel boxes (20 panels per box) = 13,700 panels
Product Description
Reason for Recall
Distribution Pattern
U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, IN, KY, MA, MI, MO, NC, NH, NY, OH, OK, PA, SC, SD, TN, TX, VA, and WI. The countries of Australia, Austria, Bahamas, Bangladesh, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam.