Cell Marque Antibodies Recall: In-vitro Diagnostics Without FDA Clearance
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.
Lower-risk recall
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62465-cell-marque-antibodies-recall-in-vitro-diagnostics-without-fda-clearance.
Source Summary by GovInfoNow · govinfonow.com/recall/62465-cell-marque-antibodies-recall-in-vitro-diagnostics-without-fda-clearance · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2106-2021
Cite this page
“Cell Marque Antibodies Recall: In-vitro Diagnostics Without FDA Clearance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62465-cell-marque-antibodies-recall-in-vitro-diagnostics-without-fda-clearance. Based on FDA recall #Z-2106-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Cell Marque- Product
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2105-2021 | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798; Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023 | 41 kits |
| Z-2106-2021 | Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513; Lot Number: 0000101423 | 2 units |
What to do — step by step
Check Product Details
Verify the product name and lot number to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed in 18 states.
FDA distribution: “US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Florida, Hawaii, Idaho, Illinois, Kentucky, Minnesota, Montana, New Hampshire, New York, North Carolina, Pennsylvania, South Carolina, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years 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-2106-2021 (May 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2106-2021 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.