SEKIS: HCG control set recall due to cold chain disruptions from thunderstorms. Products may give incorrect or delayed test results if stored outside recommended conditions. Check catalog number 138 for affected items.
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.
SEKISUI DIAGNOSTICS' HCG control sets were recalled because thunderstorms caused some to be stored outside recommended cold conditions. This could lead to incorrect or delayed test results if the products are used without proper storage.
Thunderstorms caused some products to be stored outside the recommended cold conditions. This could increase the chance of incorrect or delayed test results when used.
Healthcare providers and labs using the SEKISUI HCG control sets with catalog number 138 are most at risk. Patients relying on these tests for pregnancy detection may see inaccurate results if the control sets are not stored properly.
Check for catalog number 138 on the product label. The product was sold with GTIN 742860100093 and order number 45402895.
Ensure the control set is stored at the recommended cold temperature if you have it.
Thunderstorms caused some products to be stored outside recommended cold conditions, which could lead to incorrect or delayed test results.
Look for catalog number 138 on the product label. The product was sold with GTIN 742860100093 and order number 45402895.
No, but ensure it's stored at the recommended cold temperature to avoid incorrect or delayed test results.
We’ve drafted a message you can send SEKISUI DIAGNOSTICS to request your refund or repair — edit it as you like.
Subject: Recall Z-1854-2025 — SEKISUI DIAGNOSTICS SEKISUI DIAGNOSTICS Hello, I own a SEKISUI DIAGNOSTICS that is covered by recall Z-1854-2025 from SEKISUI 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.
