Skip to content
Lower risk Medical device recall · FDA · Published July 22, 2021

BD Mouse IgG2a Isotype Control APC X39 ASR: False Positive Staining Risk

BD Biosciences recalls Mouse IgG2a Isotype Control APC X39 ASR due to potential false positive staining from contamination. Affected units have catalog number 340757 and lot number 0253432.

🇺🇸 FDA recall #Z-2333-2021Medical deviceBD Biosciences ›
Take action

Contact the company

Recalling firmBecton, Dickinson and Company, BD Biosciences2350 Qume Dr · San Jose, CA 95131-1812
✎ GovInfoNow plain-language explainer

BD Biosciences is recalling their Mouse IgG2a Isotype Control APC X39 ASR product because it may cause false positive staining results due to contamination during manufacturing. This could lead to inaccurate laboratory test outcomes. Read more at govinfonow.com/recall/62173-bd-mouse-igg2a-isotype-control-apc-x39-asr-false-positive.

Source Summary by GovInfoNow · govinfonow.com/recall/62173-bd-mouse-igg2a-isotype-control-apc-x39-asr-false-positive · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2333-2021

Cite this page

“BD Mouse IgG2a Isotype Control APC X39 ASR: False Positive Staining Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62173-bd-mouse-igg2a-isotype-control-apc-x39-asr-false-positive. Based on FDA recall #Z-2333-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2333-2021%22&limit=1).

The FDA announced on July 22, 2021, that BD Biosciences is recalling BD Mouse IgG2a Isotype Control APC X39 ASR due to potential false positive staining. The hazard stems from a manufacturing error causing contamination with another antibody.

How to tell if you have it

  • Brand: BD Biosciences
  • Product: BD Mouse IgG2a Isotype Control APC X39 ASR
  • Catalog Number: 340757
  • Lot Number: 0253432

The hazard

Complaints indicate performance issues related to high background and staining. This issue is linked to a manufacturing process error that can potentially cause false positive staining due to contamination with another antibody.

Context

GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has had 10 other recalls on record since May 16, 2018. Other recent recalls of similar products include BD Multitest 6-Color TBNK Kit Recall (May 8, 2024) and BD Biosciences CD11b APC Recall (Oct. 25, 2023). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and S. Typhi/Para Ty Recall (Nov. 22, 2025).

How to tell if you have this one

Check for catalog number 340757 and lot number 0253432 on the product label. This specific product was sold by BD Biosciences for laboratory use.

  • Brand
    BD Biosciences
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the catalog number 340757 and lot number 0253432 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Florida, Kentucky, New York, Pennsylvania.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jul 22, 202112. FDA classified it Class II: Aug 24, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: Mar 24, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

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-2333-2021 (July 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2333-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA