Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0172-2023

Z-0172-2023 Class II Ongoing

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

FDA device recall Z-0172-2023 was initiated by Becton, Dickinson and Company, BD Biosciences on October 3, 2022 and is designated Class II. 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 ca… The recall status is ongoing. Affected quantity: 11,709 tubes (corrected 11/04/2022).

Recall Details

Product Type: Devices
Report Date: November 9, 2022
Initiation Date: October 3, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,709 tubes (corrected 11/04/2022)

Product Description

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.

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 Pattern

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

Code Information

Corrected as of 11/04/2022: Catalog Number: 663028 UDI-DI Code: 00382906630285 Lot Numbers: 2031238 2063994 2095615 2145791 2221697 2237045

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