CSL Behring Recalls N Latex CDT Kits Due to Measurement Bias
CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may lead to incorrect diagnostic results (false negatives), which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CSL Behring GmbH is recalling 6,635 units of the N Latex CDT Kit. The recall covers specific lots with expiration dates ranging from June 2018 to March 2019. The product was distributed domestically in Delaware, Indiana, Kansas, Missouri, and Virginia, as well as internationally in numerous countries including Australia, Canada, China, and the United Kingdom.
The recall was initiated because Siemens Healthcare Diagnostics observed a negative bias in carbohydrate-deficient transferrin (CDT) measurements when using the affected kits. This bias results in calculated %CDT values that are approximately 15% lower than those obtained using the HPLC method. There are no control or calibrator materials available that would detect this specific bias.
This inaccuracy could cause weak positive patient samples to be incorrectly classified as falling within the normal reference range. Healthcare providers and laboratories should stop using the affected lots and contact CSL Behring for further instructions.
The recalled product
- Product
- N Latex CDT Kit
- Manufacturer
- CSL Behring GmbH
- Affected units
- 6,635
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI - 842768018534 Lot # 47169
- Exp Date: 2018-06-15 Lot # 47596
- Exp Date: 2018-11-30 Lot # 47716
- Exp Date: 2018-11-30 Lot # 48084
- Exp Date: 2019-03-21 Lot # 48168
- Exp Date: 2019-03-21
Distribution
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