BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are
Summary
The FDA issued a Class II for BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leu by Becton, Dickinson and Company, BD Biosciences. Reason: 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 aut.
Details
Source
Device Recall
External ID
Z-0171-2023
Action Date
2022-11-09
Status
Ongoing
Category
device
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.
Lot/Code Info: Added/Corrected as of 11/04/2022: Catalog Number: 340334 UDI-DI Code: 00382903403349 Lot Numbers: 2031144 2034642 2035110 2035121 2060660 2073297 2073298 2095186 2101458 2108676 2112862 2152055 2152064 2152068 2152075 2152080 2203024 2208091 2215812 2235269 2223229 2236782 2236934 2236936 2236937 2236783 2237006 2237008 2237012 2237014 2237015 2237016
Quantity Affected: 52,570 tubes (corrected on 11/04/2022)
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. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-03
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton, Dickinson and Company, BD Biosciences has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton, Dickinson and Company, BD Biosciences) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton, Dickinson and Company, BD Biosciences have FDA actions?
Becton, Dickinson and Company, BD Biosciences has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0171-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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