Cell Marque recalls Rabbit Monoclonal Antibody (REF: 117R-18) distributed without FDA clearance for in-vitro diagnostics use. Affected lots expire by Dec 2021 to May 2023. Contact for details.
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Cell Marque is recalling a specific rabbit monoclonal antibody product that was sold without FDA clearance for in-vitro diagnostic use. This means the product may not be safe or effective for its intended purpose without proper regulatory approval.
The product was distributed for in-vitro diagnostics use without FDA clearance. This means it may not meet safety or effectiveness standards required for medical testing, potentially leading to inaccurate results or unsafe practices.
Researchers and labs using this antibody for in-vitro diagnostics may be affected. Those with the specific lot numbers listed are most at risk.
Check the product label for the lot number: 0000058081 (expiring Dec 2021), 0000072580 (expiring Sep 2021), 0000090505 (expiring Sep 2022), or 0000121052 (expiring May 2023).
Look for the lot number on the label to confirm if it matches the affected lots listed.
The recall states the product was distributed without FDA clearance for in-vitro diagnostics use, so it may not be safe or effective without proper regulatory approval.
The recall does not specify a remedy, so contact Cell Marque directly for guidance on next steps.
Check the product label for the lot numbers: 0000058081 (expiring Dec 2021), 0000072580 (expiring Sep 2021), 0000090505 (expiring Sep 2022), or 0000121052 (expiring May 2023).
We’ve drafted a message you can send Cell Marque to request your refund or repair — edit it as you like.
Subject: Recall Z-2105-2021 — Cell Marque Cell Marque Hello, I own a Cell Marque that is covered by recall Z-2105-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
