Stanbio recalls RaPET RF Latex Reagent used in rheumatoid arthritis tests due to weakly positive results in patient serum samples. Affected kits include RaPET RF (1155-100) and others with specific expiry dates.
All patient serum samples yield a weakly positive test result.
Stanbio is recalling RaPET RF Latex Reagent used in rheumatoid arthritis tests because it causes weakly positive results in patient serum samples. This could lead to incorrect diagnoses if not addressed.
The reagent causes patient serum samples to show weakly positive results, which may lead to incorrect diagnoses of rheumatoid arthritis. This happens because the reagent is not functioning properly in the test.
People using rheumatoid arthritis test kits that include the recalled RaPET RF Latex Reagent are affected. Those with recent test results using the specific lot numbers are most at risk.
Check if your rheumatoid arthritis test kit includes the RaPET RF reagent with lot number 21675. The kits are labeled with specific model numbers and expiry dates.
Look for the lot number 21675 on the reagent packaging.
The RaPET RF Latex Reagent used in rheumatoid arthritis test kits with lot number 21675.
It causes patient serum samples to yield weakly positive test results, which could lead to incorrect diagnoses.
Check for the lot number 21675 on the reagent packaging. Affected kits include RaPET RF (1155-100) and others with specific expiry dates.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2018 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-1070-2018 from Stanbio. 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.
