CSL Behring recalls specific N Latex CDT Kit lots due to potential negative bias in carbohydrate-deficient transferrin (CDT) results compared to HPLC method, which could shift weak positive samples into reference range.
Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19 2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.
CSL Behring is recalling specific lots of N Latex CDT Kit due to a negative bias in carbohydrate-deficient transferrin (CDT) measurements. This could cause weak positive patient samples to appear within the normal reference range, potentially leading to incorrect diagnoses.
The recalled kits show a negative bias of about 15% in CDT results compared to the HPLC method. This could cause weak positive samples to fall into the normal reference range (1.19-2.47 %CDT), potentially leading to missed diagnoses.
Healthcare providers using the recalled N Latex CDT Kit lots for patient testing. Patients with specific conditions may be at risk of incorrect diagnosis if the kit is used.
Check for the lot numbers: 47169 (exp 2018-06-15), 47596 (exp 2018-11-30), 47716 (exp 2018-11-30), 48084 (exp 2019-03-21), and 48168 (exp 2019-03-21).
Look for the lot numbers listed: 47169 (exp 2018-06-15), 47596 (exp 2018-11-30), 47716 (exp 2018-11-30), 48084 (exp 2019-03-21), and 48168 (exp 2019-03-21).
The recalled N Latex CDT Kit shows a negative bias of about 15% in carbohydrate-deficient transferrin (CDT) results compared to the HPLC method, which could cause weak positive samples to fall into the normal reference range.
The recall record does not specify a remedy, so no action is required beyond checking the lot numbers.
The recall record indicates a potential shift in results but does not mention serious injury or death. The risk is considered low.
We’ve drafted a message you can send CSL Behring to request your refund or repair — edit it as you like.
Subject: Recall Z-2931-2018 — CSL Behring CSL Behring Hello, I own a CSL Behring that is covered by recall Z-2931-2018 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.
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.
