FDAFDA · Food and drugs·Recall number Z-0173-2023
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
Published November 9, 2022 · Recall initiated: October 3, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Distributor
- U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay
- Lot
- Corrected as of 11/04/2022: Catalog Number: 662995 UDI-DI Code: 00382906629951 Lot Numbers: 11568 45905 53637 88003 89111 31905
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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