Siemens N Latex CDT Kit may show inaccurate results after 15 months. Recalled due to negative bias in carbohydrate-deficient transferrin measurements compared to HPLC method. No remedy specified.
Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
The Siemens N Latex CDT Kit for measuring carbohydrate-deficient transferrin in blood may give inaccurate results after 15 months of shelf life. This could lead to incorrect medical diagnoses if used without the kit being replaced.
The kit may show negative bias in carbohydrate-deficient transferrin measurements after 15 months of shelf life. This means results could be lower than actual values compared to the HPLC method, potentially leading to incorrect medical decisions.
Healthcare providers using the Siemens N Latex CDT Kit for blood tests may be affected. Patients receiving results from this kit could be at risk of incorrect diagnoses if the kit is used after its expiration date.
Check for Siemens Material Number (SMN) 10445997, US Lot numbers 49822, or expiration date 2020-04-11. The kit is labeled for IVD quantitative determination of carbohydrate-deficient transferrin in human serum.
Verify the expiration date on the kit label; if it's after 2020-04-11, it may be affected.
The recall is for potential inaccurate results after 15 months, not immediate danger. The kit is safe if used before expiration.
Look for Siemens Material Number 10445997, US Lot number 49822, or expiration date 2020-04-11.
No remedy is specified, so you don't need to stop using it. Check expiration date and use before 2020-04-11.
We’ve drafted a message you can send CSL Behring to request your refund or repair — edit it as you like.
Subject: Recall Z-1790-2020 — CSL Behring CSL Behring Hello, I own a CSL Behring that is covered by recall Z-1790-2020 from CSL Behring. 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.
