BD Trucount Tubes — Class II medical device recall Z-0172-2023
Ongoing recall by Becton, Dickinson and Company, BD Biosciences, reported 2022-11-09, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause
| Recall number | Z-0172-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2022-10-03 |
| Classified | 2022-11-03 |
| Reported by FDA | 2022-11-09 |
| Distributed | 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, WI |
| Countries outside the US | AR, AU, BE, BO, BR, CA, CL, CN, CR, DO, EC, GT, HK, IN, JP, KR, MX, MY, NZ, PA, PE, PH, PY, SG, SV, TH, TW, UY |
| Reason classes | labeling, device malfunction |
| UPC / GTIN / UDI-DI | 00382906630285 |
| Lot numbers | 2031238, 2063994, 2095615, 2145791, 2221697, 2237045 |
| Model numbers | 663028 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0172-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.