CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- Recall Initiated
- October 25, 2023
- Posted
- January 5, 2024
- Recall Number
- Z-0641-2024
- Quantity
- 464 Vials
- Firm Location
- San Jose, CA
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.
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.
Lot / Code Info
REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
Root Cause
Nonconforming Material/Component
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