Lower riskMedical device recall · FDA · Published July 15, 2021
Cell Marque Antibodies Recall: Incorrect Expiry Date Risk
Cell Marque recalls specific antibodies due to incorrect expiry date (2023 listed vs 2022 correct). Using expired product may cause false negatives and delay diagnosis.
Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
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Contact the company
📍Recalling firmCell Marque Corporation6600 Sierra College Blvd · Rocklin, CA 95677-4306
✎ GovInfoNow plain-language explainer
Cell Marque is recalling two specific antibody products because they were labeled with an incorrect expiry date. Using these expired products could lead to false negative results, potentially delaying diagnosis of conditions like prostate cancer. Read more at govinfonow.com/recall/62204-cell-marque-antibodies-recall-incorrect-expiry-date-risk.
“Cell Marque Antibodies Recall: Incorrect Expiry Date Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62204-cell-marque-antibodies-recall-incorrect-expiry-date-risk. Based on FDA recall #Z-2311-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2311-2021%22&limit=1).
The FDA announced on July 15, 2021, that Cell Marque Corporation is recalling PSA (ER-PR8) Mouse Monoclonal Antibodies due to an incorrect expiry date. The hazard poses a risk of false negative results and delayed diagnosis if the product is used beyond its actual expiration.
The antibodies were labelled with an incorrect expiry date of Dec. 31, 2023, instead of the correct date of Dec. 31, 2022. If used beyond the actual expiry, material performance may decrease, resulting in weak or no staining and a potential risk of false negative results that could lead to delayed diagnosis due to retest.
Context
GovInfoNow's records show Cell Marque Corporation has one other recall on record since May 27, 2021. On May 27, 2021, the company issued a recall for In-vitro Diagnostics without FDA clearance. Other recent recalls of similar products include LimFlow Vector Product Recall (Dec. 5, 2025), Exploro Fertility Test Recall (Nov. 22, 2025), and Cardinal Health ChemoPlus Gowns Recall (Nov. 12, 2025).
How to tell if you have this one
Check for the product code REF: 324M-15 or 324M-16 with lot numbers 0000116695 or 0000116696. The antibodies are sold by Cell Marque Corporation.
Brand
Cell Marque
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiry Date
Verify the expiry date on the product label; the correct date is December 31, 2022.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, New Jersey, Oregon.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2311-2021 (July 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2311-2021 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.