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.
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
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.
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.
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.
Check for product number R30165501 and lot number 2407976 on the serum container. The product was sold with specific UDI-DI: 05056080501826.
Verify the product number R30165501 and lot number 2407976 on the serum container.
The Remel Bordetella pertussis agglutinating serum with product number R30165501 and lot number 2407976.
The serum may not perform correctly, leading to false negative results for serotypes 1 and 3 in diagnostic tests.
The recall record does not specify a remedy, so check the product details and contact Remel for further guidance.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-2920-2020 — Remel Remel Hello, I own a Remel that is covered by recall Z-2920-2020 from Remel. 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.
