CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias
CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic inaccuracy (negative bias) rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity recall involving a medical device with potential for adverse health consequences through misdiagnosis.
Plain-English summary
CSL Behring GmbH is recalling the Siemens N Latex CDT Kit, an in vitro diagnostic (IVD) product used for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. The recall affects 297 packages in the United States and 1,247 packages outside the United States. The affected US lot number is 49822, and the expiration date is April 11, 2020.
The recall was initiated because shelf life monitoring observed negative bias in the CDT measurement results when compared to the HPLC method. This bias was observed to occur after 15 months of storage. The product was distributed in the US states of Indiana, Kansas, Missouri, Ohio, and Virginia, as well as in numerous foreign countries including Australia, Canada, China, Germany, and Japan.
Healthcare facilities and laboratories should stop using the affected lots of the Siemens N Latex CDT Kit. Users should contact CSL Behring GmbH for further instructions on returning or disposing of the product. No specific instructions for individual consumers are provided as this is a professional in vitro diagnostic product.
The recalled product
- Product
- Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
- Manufacturer
- CSL Behring GmbH
- Hazard
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 (4)
- US Lot number: 49822 UDI: 842768018534 OUS: Lot numbers: 49729
- 49849
- 49985
- 50084 Exp. Date: 2020-04-11
Distribution
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