Bio-Rad recalls BioPlex 2200 Syphilis Reagent Packs due to potential false positive RPR results from COVID vaccinations or shelf-life issues. Affected units may show incorrect syphilis test results.
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Bio-Rad is recalling its BioPlex 2200 Syphilis Total & RPR Reagent Packs because they may produce false positive results for syphilis tests, especially after COVID vaccinations. This could lead to incorrect diagnoses if used without proper verification.
The kit may show false positive results for syphilis due to two issues: a possible correlation with COVID vaccinations and a shelf-life problem causing elevated reactivity. This could lead to incorrect diagnoses if the test is used without proper verification.
People who use this syphilis test kit for medical testing are affected. Those who have recently received COVID vaccinations may be at higher risk of false positive results.
Check for the product name 'BioPlex 2200 REF 12000650 SYPH T PACK' on the label. The UDI code is 03610520653012 and lot number 301210.
Look for the UDI code 03610520653012 and lot number 301210 on the reagent pack.
The recall is due to potential false positive results for syphilis tests, which could be caused by a correlation with COVID vaccinations or early shelf-life failure.
No, the recall does not require stopping use immediately. However, users should verify results with a different test if they have received recent COVID vaccinations.
Check for the UDI code 03610520653012 and lot number 301210 on the reagent pack label.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-0235-2022 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-0235-2022 from Bio-Rad. 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.
