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Lower risk Medical device recall · FDA · Published July 30, 2021

Leica BOND Antibody CDX2 Recall: Product May Not Perform as Specified

Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (EP25) REF PA0375 due to potential performance issues. Affected units may not function correctly as per instructions.

🇺🇸 FDA recall #Z-2481-2021Medical deviceLeica ›
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Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
✎ GovInfoNow plain-language explainer

What happened, in plain English

Leica Microsystems is recalling a specific antibody product because it might not work properly as described in the user manual. This could affect lab results or experiments if the product doesn't perform as intended. Read more at govinfonow.com/recall/62111-leica-bond-antibody-cdx2-recall-product-may-not-perform-as.

Source Summary by GovInfoNow · govinfonow.com/recall/62111-leica-bond-antibody-cdx2-recall-product-may-not-perform-as · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2481-2021

Cite this page

“Leica BOND Antibody CDX2 Recall: Product May Not Perform as Specified.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62111-leica-bond-antibody-cdx2-recall-product-may-not-perform-as. Based on FDA recall #Z-2481-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2481-2021%22&limit=1).

Why it’s dangerous

The product may not function correctly as specified in the user manual. This could lead to inaccurate lab results or failed experiments if the antibody doesn't perform as intended.

Who’s affected

Lab researchers and scientists using this antibody product in their work. Those who have the specific product code PA0375 are most at risk.

How to tell if you have this one

Check for the product code PA0375 and lot number 69909 on the label. The product is a Ready-To-Use Primary Antibody CDX2 (EP25) from Leica Microsystems.

  • Brand
    Leica
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product code PA0375 and lot number 69909 on the label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Jul 30, 202112. FDA classified it Class II: Sep 16, 202123. Published in FDA’s Enforcement Report: Sep 22, 202134. FDA terminated the recall: Jun 22, 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.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall states the product may not perform as specified in the user manual, but it does not indicate a safety hazard like injury or fire. This is a performance issue, not a safety risk.

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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-2481-2021 (July 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2481-2021 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