FDA-Device2024-01-17Class II
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Hazard
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.
Sold states
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.
Affected count
464 Vials
Manufactured in
2350 Qume Dr, San Jose, CA, United States
Products
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2024Don't want to check this manually?
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