BD Trucount recallZ-0171-2023 · Becton, Dickinson and Company, BD Biosciences · initiated Oct 3, 2022

Why it was recalled

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. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected]

Recall details

Recall number

Z-0171-2023

Status

Open, Classified

Initiated by the company

Oct 3, 2022

Posted by the FDA

Nov 3, 2022

Recalling firm

Becton, Dickinson and Company, BD Biosciences

Quantity

52,570 tubes (corrected on 11/04/2022)

Product code

GKZ

FDA submissions

K090967

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

Product description

BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD Trucount 340334

  Becton, Dickinson And Company · Counter, differential cell
  1 recall11 reports

Product lines

• BD TrucountBecton, Dickinson And Company · 3 models · 11 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 90866).

• Z-0172-2023 · Open, Classified
  BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as B…
• Z-0173-2023 · Open, Classified
  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 percentag…