Z-0172-2023Class II

BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount...

Name: Z-0172-2023 BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2022-10-03
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2022-10-03 / Open, Classified / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of 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... on 2022-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0172-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-03
Posted: 2022-11-03
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: 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 BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected]
Quantity in commerce: 11,709 tubes (corrected 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
Product codes and lots: Corrected as of 11/04/2022: Catalog Number: 663028 UDI-DI Code: 00382906630285 Lot Numbers: 2031238 2063994 2095615 2145791 2221697 2237045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0172-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0171-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0172-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-03
Z-0173-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-03

Product code GKZ

K090967Class IIBd Multitest 6-Color Tbnk Reagent, Model 644611Bd Biosciences / cleared 2009-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)