Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-1971-2020

Z-1971-2020 Class II Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
March 31, 2020
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1473 vials.

Product Description

Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.

Reason for Recall

False positive reaction on the reagent.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Puerto Rico. The countries of Argentina, Australia, Belgium, Brazil, Canada, China, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan and Vietnam.

Code Information

Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949

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