CD11b APC: ASR, REF: 340936, and CE, REF: 333143

FDA device recall Z-0641-2024 · posted 2024-01-05 · Open, Classified

Recall details

Recalling firm

Becton, Dickinson and Company, BD Biosciences

Reason for recall

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.

Action taken

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-23-4854 Customers who require further assistance can contact the firm's North American Regional Complaint Center via phone, 1-844-823-5433, say "recall" when prompted Mon-Fri 8:00am and 5:00pm CT, or via email, productcomplaints@bd.com

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

MVU

Quantity affected

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

Date initiated

2023-10-25

Date posted

2024-01-05

Location

San Jose, CA