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

Recall Insight

This FDA Devices action (record #Z-0641-2024) was formally reported on January 17, 2024, with the manufacturer initiating the action on October 25, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton, Dickinson and Company, BD Biosciences is listed as the recalling firm, operating out of San Jose, CA. Federal records indicate 464 Vials units are affected.

The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: 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, B…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.