FDAFDA · Food and drugs·Recall number Z-0720-2021
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
Published December 30, 2020 · Recall initiated: December 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10 Lot Number: 2021-06-10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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