Cell Marque recalls mouse monoclonal antibodies for in-vitro diagnostics without FDA clearance. This product may pose regulatory risks but does not indicate immediate safety hazards.
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Cell Marque is recalling a specific mouse monoclonal antibody product for in-vitro diagnostics because it was distributed without FDA clearance. This recall does not indicate an immediate safety risk to users but addresses regulatory compliance issues.
The product was distributed for in-vitro diagnostics without receiving FDA clearance. This means it may not meet U.S. regulatory standards for medical devices, but it does not indicate a physical hazard like injury or fire.
Researchers and labs using this antibody product for in-vitro diagnostics are likely affected. Those with the specific product code REF: 287M-10 are at risk.
Check for the product name 'Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10' with lot number 0000101423. This product was sold internationally under CE marking.
Verify the product name and lot number to confirm if it matches the recalled item.
No immediate safety hazard is reported; the recall addresses regulatory compliance, not physical risks.
The product was distributed for in-vitro diagnostics without FDA clearance, which is a regulatory issue.
Look for the product name 'Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10' with lot number 0000101423.
We’ve drafted a message you can send Cell Marque to request your refund or repair — edit it as you like.
Subject: Recall Z-2106-2021 — Cell Marque Cell Marque Hello, I own a Cell Marque that is covered by recall Z-2106-2021 from Cell Marque. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
