Remel Bordetella Pertussis Serum Recall: False Negative Results Risk
Remel recalls Bordetella pertussis agglutinating serum (R30165501) due to potential false negatives for serotypes 1 and 3 in tests. Affected units have specific product numbers and lot numbers.
Lower-risk recall
Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3
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What happened, in plain English
Remel is recalling its Bordetella pertussis agglutinating serum product (R30165501) because it may give false negative results for serotypes 1 and 3 in diagnostic tests. This could lead to incorrect conclusions about infections if used improperly. Read more at govinfonow.com/recall/64648-remel-bordetella-pertussis-serum-recall-false-negative-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64648-remel-bordetella-pertussis-serum-recall-false-negative-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2920-2020
Cite this page
“Remel Bordetella Pertussis Serum Recall: False Negative Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64648-remel-bordetella-pertussis-serum-recall-false-negative-results-risk. Based on FDA recall #Z-2920-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2920-2020%22&limit=1).
Why it’s dangerous
The serum may not work correctly in slide agglutination tests, leading to false negative results for serotypes 1 and 3. This means infections could be missed if the test is not properly detected.
Who’s affected
Laboratory users who test for Bordetella pertussis or Bordetella parapertussis with this serum. Those using the product for diagnostic purposes are most at risk of inaccurate results.
How to tell if you have this one
Check for product number R30165501 and lot number 2407976 on the serum container. The product was sold with specific UDI-DI: 05056080501826.
- Brand
Remel- Category
Medical device
What to do — step by step
Check Product Details
Verify the product number R30165501 and lot number 2407976 on the serum container.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of MO, CA and the countries of CA, AT, BO, CN, CZ, GB, GM, HK, IE, IT, MX, MY, NL,OM, SA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Missouri.
Recall timeline
FDA terminated this recall 20 months 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-2920-2020 (July 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2920-2020 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.