Ortho Clinical Diagnostics recalls Total Bili-Alkp Xt reagent due to potential test errors from improper cold storage during transit. Affected units may have incorrect or delayed results.
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 Total Bili-Alkp Xt reagent kits because severe thunderstorms caused some to be stored outside recommended cold conditions. This could lead to incorrect or delayed test results if used.
Severe thunderstorms caused transit delays for some reagent kits, leading to improper cold storage. This increases the chance of incorrect or delayed test results when the reagent is used.
Healthcare facilities using the reagent kits are likely affected. The risk is highest for labs that received kits during thunderstorm events.
Check for the product name 'Total Bili-Alkp Xt (L-Sequester)' with 300/pack. The catalog number is 6844296 or GTIN 10758: 750031801.
Ensure the reagent has been stored within the recommended cold conditions before use.
Severe thunderstorms caused transit delays for some reagent kits, leading to improper cold storage and potential test errors.
Look for the product name 'Total Bili-Alkp Xt (L-Sequester)' with 300/pack, catalog number 6844296, or GTIN 10758750031801.
No, but ensure it has been stored properly in cold conditions before use to avoid incorrect or delayed test results.
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-1835-2025 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-1835-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
