Recall Z-0641-2024 ยท MVU Reagents, Specific, Analyte
Becton, Dickinson and Company, BD Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
| Date | Jan 5, 2024 (initiated Oct 25, 2023) |
| Status | Open, Classified |
| Reason | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/25/2023, correction notices were mailed and emailed to customers who were asked to do the following: 1) Discard all products subject to the recall following your institution s process for destruction. 2) Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3) If lot 3114730 was used, review results and take appropriate action as deemed necessary. 4) Complete and return the response form via email, BDRC26@bd.com or via Link, https://bdx.my.site.com/CC360/s/impactedproducts?rn=BDB |
| Quantity | 464 Vials |
| Distribution | Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.