Cd11b Apc: ASR recall
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Why was Cd11b Apc: ASR recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
- Product
- CD11b APC: ASR, REF: 340936, and CE, REF: 333143
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- 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.
- Recall date
- January 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)