Device product
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.
Z-1971-2020
Product summary
- Event
- Event 85461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1473 vials.
- Official record key
device-enforcement:Z-1971-2020
Official wording
Reason: False positive reaction on the reagent.
Code information: Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949
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.
Derived failure modes
-
Unknown
False positive reaction on the reagent.