Recall Z-1971-2020— Becton, Dickinson and Company, BD Biosciences
Class II · Terminated
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2020-03-31, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: False positive reaction on the reagent..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-31
- Terminated
- 2021-04-27
- Firm location
- San Jose, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.