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.
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 2/5 (Moderate).
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.
Related recalls
Same manufacturer · Diagnostica Stago, Inc.
See all →- ModerateDiagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
FDA (Devices) · 2026-09-09
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighStago free protein S assay may underestimate normal range results
FDA (Devices) · 2026-03-11
- HighLucky Ice mouthwash recalled over insanitary conditions at a distribution center
FDA (Devices) · 2026-01-21
- HighD-Dimer test reagents recalled over potential underestimation of measured levels
FDA (Devices) · 2025-10-22
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateDiagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability
FDA (Devices) · 2018-12-26
- ModerateDiagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
FDA (Devices) · 2020-01-01
- HighSTA Compact Max analyzer firmware bug causes inaccurate test results
FDA (Devices) · 2023-05-17
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- ModerateDiagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability
FDA (Devices) · 2018-12-26
- ModerateDiagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect
FDA (Devices) · 2018-03-21