Diagnostica Stago Recalls LIATEST VWF:Ag Coagulation Assay Kits
Diagnostica Stago is recalling LIATEST VWF:Ag kits because measurement errors may lead to lowered percentage 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 hazard involves inaccurate test results rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Diagnostica Stago, Inc. is recalling 2,901 kits of the LIATEST VWF:Ag Coagulation Assay. The affected products include the LIATEST VWF:Ag Buffer, LIATEST VWF:Ag Latex +, and LIATEST VWF:Ag Latex Diluent, distributed in the United States and Canada.
The recall was initiated because the company confirmed that the delta OD measured can sometimes change, leading to a lowered percentage result. This issue affects the accuracy of the coagulation assay results.
Healthcare providers and laboratories should stop using the affected lots and contact Diagnostica Stago for further instructions. The affected lot numbers are 108128, 108512, 108778, 109415, and 109591.
The recalled product
- Product
- Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- Affected units
- 2,901
Distribution
Distribution scope not specified by the agency.
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