Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR kit due to potential increased RPR reactivity in specific lots. Affected kits may produce inaccurate results for syphilis testing.
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Bio-Rad is recalling certain lots of their BioPlex 2200 Syphilis Total & RPR kit because the RPR reactivity level is higher than expected. This could lead to inaccurate syphilis test results, which is important for proper diagnosis and treatment.
The kit's RPR reactivity level is higher than intended, which can cause false positive results in syphilis testing. This means the test might incorrectly indicate that someone has syphilis when they do not, or vice versa.
People who use the BioPlex 2200 Syphilis Total & RPR kit for syphilis testing are affected. Those who have recently used the kit with the specific UDI 03610520653012 and lot numbers 301142 or later are most at risk.
Check the kit's unique device identifier (UDI) 03610520653012 and lot numbers. The affected kits will have lot numbers starting from 301142 or later.
Look for the unique device identifier (UDI) 03610520653012 and lot numbers starting from 301142 or later on the kit.
The recall is due to increased RPR reactivity in specific lots of the BioPlex 2200 Syphilis Total & RPR kit, which can lead to inaccurate syphilis test results.
Check the kit's UDI and lot number. If it matches the affected details, you should stop using it and contact Bio-Rad for further instructions.
The official recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-2982-2020 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-2982-2020 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.
