Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR Calibrator Set (12000651) due to potential false positive RPR results from COVID vaccinations and stability 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 Calibrator Set (model 12000651) because it may produce false positive results for syphilis tests, especially after COVID vaccinations. This could lead to incorrect diagnoses if used in testing.
The calibrator set may show false positive results for syphilis tests due to a correlation with COVID vaccinations. Additionally, the product might become unstable over time, causing elevated RPR reactivity that could lead to incorrect test results.
People using this calibrator set for syphilis testing may be affected, particularly those who have received COVID vaccinations and are testing for syphilis. The risk is higher for laboratory users handling the product.
Check for the model number 12000651 on the calibrator set. The product was sold with UDI code 03610520652770 and lot number 52953.
Look for the model number 12000651 and UDI code 03610520652770 on the calibrator set.
The recall is due to potential false positive RPR results from COVID vaccinations and stability issues that could cause elevated reactivity.
The recall does not specify a stop-use instruction, so you can continue using it if you have no symptoms of false positives.
Check for model number 12000651 and UDI code 03610520652770 on the calibrator set.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-0236-2022 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-0236-2022 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.
