BD Biosciences Analyte Reagent False Positive Recall: Stop Using for Accurate Results
BD Biosciences recalls Analyte specific reagent due to false positive reactions. Affected units have REF/UDI codes listed. Users should stop using to avoid inaccurate test results.
Lower-risk recall
False positive reaction on the reagent.
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What happened, in plain English
BD Biosciences is recalling Analyte specific reagent (CD45 APC-H7) because it can cause false positive reactions in flow cytometry tests. This could lead to incorrect cell identification results in laboratory settings. Read more at govinfonow.com/recall/65590-bd-biosciences-analyte-reagent-false-positive-recall-stop-using-for.
Source Summary by GovInfoNow · govinfonow.com/recall/65590-bd-biosciences-analyte-reagent-false-positive-recall-stop-using-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1971-2020
Cite this page
“BD Biosciences Analyte Reagent False Positive Recall: Stop Using for Accurate Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65590-bd-biosciences-analyte-reagent-false-positive-recall-stop-using-for. Based on FDA recall #Z-1971-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1971-2020%22&limit=1).
Why it’s dangerous
The reagent can produce false positive reactions when used in flow cytometry tests, leading to incorrect identification of CD45 antigen-expressing cells. This may cause misdiagnosis or incorrect data interpretation in laboratory settings.
Who’s affected
Laboratory users who have the affected reagent for in vitro diagnostic testing. Researchers and medical professionals using flow cytometers with this reagent are most at risk of inaccurate results.
How to tell if you have this one
Check for REF/UDI codes: 641408/641408-4012-1-1 (US), 641417/641417-1157-1-01 (OUS), or 641399/641399-4012-1-01 (US Research Use Only). The product is BD CD45 APC-H7 reagent for flow cytometry.
- Brand
BD Biosciences- Category
Medical device
What to do — step by step
Stop Using Reagent
Discontinue use of the affected reagent to prevent false positive reactions in flow cytometry tests.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 29 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Puerto Rico. The countries of Argentina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1971-2020 (March 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1971-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.