Siemens Factor VIII Chromogenic Assay Recalled for Irregular Curves
Siemens Healthcare Diagnostics is recalling Factor VIII Chromogenic Assay kits due to irregular curves on specific Sysmex systems, which may cause erroneously increased results.
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, and the source text describes a potential for erroneous results without reporting any specific patient injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm is theoretical or unreported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Factor VIII Chromogenic Assay kits (REF/Catalog No. B4238-40, SMN 10445729, Lot 44637) due to quality issues. The recall involves 52 kits distributed domestically in the United States and 623 kits distributed internationally.
The recall was initiated because the assay is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 Systems. This issue could lead, under certain circumstances, to an erroneously increased result in Factor VIII Chromogenic Assay measurements.
The affected lots were distributed worldwide, including in the United States (Massachusetts) and in Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain, and Sweden. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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 (2)
- Lot Number 44637
- exp. 2016-11-30
Distribution
Distributed in 1 state:
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