Ortho Clinical Diagnostics recalls Bioclone 1:10ml test kits due to potential storage issues from thunderstorms. Products may give incorrect or delayed test results if not kept at proper cold temperatures.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Ortho Clinical Diagnostics is recalling Bioclone 10ml test kits because severe thunderstorms may have caused them to be stored outside recommended cold conditions. This could lead to incorrect or delayed test results if the products are used without proper storage.
Severe thunderstorms caused transit delays for some cold chain products, leading to improper storage conditions. This could increase the chance of incorrect or delayed test results if the products are used without being kept at the recommended cold temperatures.
Users of Ortho Bioclone 10ml test kits purchased between 2023 and 2024 are affected. People who have used these kits without proper cold storage may be at risk of incorrect or delayed results.
Check for the product name 'Bioclone 10ml' with catalog number 6901935 or GTIN 10758750007448. Products were sold between 2023 and 2024.
Ensure the test kits are stored at the recommended cold temperature before use.
Severe thunderstorms caused transit delays for some cold chain products, which may have led to improper storage conditions and increased risk of incorrect or delayed test results.
Look for the product name 'Bioclone 10ml' with catalog number 6901935 or GTIN 10758750007448. Products were sold between 2023 and 2024.
Ensure the test kits are stored at the recommended cold temperature before use. The recall does not require discarding or returning the product.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2025 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-1836-2025 from Ortho Clinical Diagnostics. 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.
