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U.S. Department of Health and Human Services

Class 2 Device Recall BD Multitest 6Color TBNK

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  Class 2 Device Recall BD Multitest 6Color TBNK see related information
Date Initiated by Firm October 03, 2022
Date Posted November 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0173-2023
Recall Event ID 90866
510(K)Number K090967  
Product Classification Counter, differential cell - Product Code GKZ
Product BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
Code Information Corrected as of 11/04/2022: Catalog Number: 662995 UDI-DI Code: 00382906629951 Lot Numbers: 11568 45905 53637 88003 89111 31905
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Troy Kirkpatrick
408-954-2100
Manufacturer Reason
for Recall		 Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 10/03/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via FedEx tracked letters and emails informing customers, through internal investigations, the labels applied to the BD Trucount tubes are becoming detached due to an adhesive change made at a supplier. Customers are instructed to: 1. Immediately review their inventory for the specific catalog and lot numbers. 2. For any tubes where label detachment is observed, BD recommends that the clinician remove the label from the tube and, using a permanent marker, record the tube lot number as well as any other relevant information directly on the tube. Removal of the label prevents it from interfering with any auto-loading sample preparation and analysis systems, as well as from sticking to other tubes. For questions, contact North American Regional Complaint Center at: Phone: 1-844-8BD-LIFE (1-844-823-5433), Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Quantity in Commerce 1,457 tubes (corrected on 11/04/2022)
Distribution U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BD Biosciences
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