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.
- Recall Initiated
- March 31, 2020
- Posted
- May 13, 2020
- Terminated
- April 27, 2021
- Recall Number
- Z-1971-2020
- Quantity
- 1473 vials.
- Firm Location
- San Jose, CA
Reason for Recall
False positive reaction on the reagent.
Distribution
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.
Lot / Code Info
Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949
Root Cause
Nonconforming Material/Component
Action Taken
URGENT MEDICAL DEVICE RECALL letter was sent to the customers on 03/31/2020 via FedEx, emailed or faxed. The acknowledgement form included with the letter that is mailed, faxed, emailed, back to BD will be reconciled with the customer list.