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U.S. Department of Health and Human Services

Class 2 Device Recall CD45 APCH7

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  Class 2 Device Recall CD45 APCH7 see related information
Date Initiated by Firm March 31, 2020
Date Posted May 13, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1971-2020
Recall Event ID 85461
Product Classification Reagents, specific, analyte - Product Code MVU
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.
Code Information Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Ms. Gail Griffiths
410-316-4054
Manufacturer Reason
for Recall		 False positive reaction on the reagent.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 1473 vials.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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